Cases of ICP were reported in pregnant patients receiving azathioprine or 6-mercaptopurine to treat inflammatory bowel disease (ulcerative colitis and Crohn disease) or systemic lupus erythematosus. While not FDA-approved to treat these diseases, some guidelines suggest azathioprine or 6-mercaptopurine may be appropriate on an individualized basis to manage certain immunologic conditions during pregnancy.  

In response to these reports, the FDA is requiring manufacturers add additional warnings related to the risk of ICP with thiopurines. These include the following:

• Postmarketing cases of ICP have been reported in women treated with drugs in the thiopurine class during pregnancy. 
• ICP symptoms and elevated bile acid levels improved following azathioprine discontinuation. 
• Pregnant persons should discontinue use of thiopurines if they develop ICP. 

Adverse events related to medication use should be reported to the FDA’s MedWatch program.

Sapropterin Dihydrochloride Powder for Oral Solution is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients 1 month of age and older with hyperphenylalaninemia due to tetrahydrobiopterin-responsive phenylketonuria.

The affected products were distributed nationwide to wholesalers and retailers, and include the following lots:

• Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg; NDC Number 43598-097-30
  • Lot # T2202812; Expiration date 7/2025
  • Lot # T2204053; Expiration date 10/2025
  • Lot # T2300975; Expiration date 2/2026
  • Lot # T2300976; Expiration date 2/2026
  • Lot # T2304356; Expiration date 8/2026
• Sapropterin Dihydrochloride Powder for Oral Solution 100mg; NDC Number 43598-477-30
  • Lot # T2200352; Expiration date 12/2024

Continuous administration of a subpotent product could lead to chronically elevated Phe levels that may result in potentially serious adverse events. At this time, there have been no reports of injury related to this recall.  

Adverse events related to this recall should be reported to FDA’s MedWatch Adverse Event Reporting program.

“The safety and effectiveness of over-the-counter anti-choking devices have not been established; they are not FDA approved or cleared,” the agency said in a safety communication issued Monday.

The FDA admitted that it is “not aware of any serious injuries reported with the use of these devices, and no deaths have been associated with the use of anti-choking devices.” However, the agency is concerned that fumbling with these one-use-only devices could cost precious time in an emergency.

The leading device, the $70 LifeVac, comes with a mask that fits over a person’s nose or mouth and attaches to a plunger-like bellows. Pushing the bellows down and then quickly up creates a vacuum to clear the airway.

The LifeVac website contains a “Hall of Saves” presenting thousands of cases in which the device has saved a child or adult from choking, as well as a page devoted to medical journal articles about the gadget.

The company informs consumers that the LifeVac is “FDA registered as a Class II medical device,” adding that “it is exempt from premarket clearance. The FDA does not require a premarket review of the LifeVac device. Currently, in the United States, all portable suction devices are required to be registered with the FDA, not approved.”

Still, the FDA says people should not rely on these devices because established choking rescue protocols, which rely on the Heimlich, “have a high rate of success and can be carried out immediately without devices, saving valuable time.”

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The discontinuation of postmarketing quality, regulatory and pharmacovigilance activities means that the Company is unable to support or guarantee that the medications will meet all intended specifications through the labeled shelf life of the product.

The affected products include:

• Cloderm (clocortolone pivalate) 0.1% cream; 45g tube; NDC# 71403-0804-45; Lot#/Expiry dates:  SDFC- 5/31/2024 and TFBW- 5/31/2025;
• Minolira (minocycline) ER 105mg tablet; 30-count bottle; NDC# 71403-0101-30; Lot#/Expiry dates: T2300765- 11/30/2025, T2201702A-02/28/2025, T2201699- 2/28/2025, and T2201698- 2/28/2025; and
• Minolira (minocycline) ER 135mg tablet; 30-count bottle; NDC# 71403-102-30; Lot#/Expiry dates: T2201700- 02/28/2025 and T2201701- 02/28/2025.

According to the Company, only the products and lot numbers listed are affected by this recall. Further distribution or use of these recalled products should be discontinued immediately. Products with lot numbers not included in this list are owned and distributed by a different company and will remain on the market.

To date, the Company has not received any reports of adverse events related to this recall. Adverse events or quality issues should be reported to the FDA’s MedWatch Adverse Event Reporting program.

Treprostinil is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (WHO Group 1) to diminish symptoms associated with exercise; and for patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The treatment is administered by either subcutaneous or intravenous infusion.

The recall (NDC #42023-206-01) includes the following lots, which were distributed nationwide to wholesalers and hospitals between June 16, 2022 and August 7, 2023: 

• Lot # 57014; Expiration date 4/2024
• Lot # 56911; Expiration date 4/2024
• Lot # 58528; Expiration date 5/2024
• Lot # 58529; Expiration date 5/2024
• Lot # 60064; Expiration date 7/2024
• Lot # 60075; Expiration date 7/2024
• Lot # 67939; Expiration date 3/2025

At this time, there have been no reports of adverse events associated with this recall. Administration of an injectable product that contains particulates can result in local adverse reactions (eg, irritation, swelling) and potentially serious systemic events (eg, stroke, death).

Adverse reactions and quality issues should be reported to the FDA’s MedWatch program.

The updates were prompted by findings from an investigation of reports describing mature T-cell malignancies among patients treated with these therapies. The classwide labeling changes apply to the following products: Abecma (idecabtagene vicleucel), Breyanzi (lisocabtagene maraleucel), Carvykti (ciltacabtagene autoleucel), Kymriah (tisagenlecleucel), Tecartus (brexucabtagene autoleucel), and Yescarta (axicabtagene ciloleucel).

According to the FDA, the risk of T-cell malignancy is applicable to all BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies. To prepare these treatments, a patient’s own T-cells are reprogrammed with a transgene encoding a CAR that identifies and eliminates BCMA or CD19-expressing target cells. The risk of secondary malignancy is believed to be related to the viral vectors used to transfer the genetic material.

Given the serious risk, the FDA is requiring the following safety labeling changes:

• In the Boxed Warning, the inclusion of language stating that T-cell malignancies have occurred following treatment with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies.
• An update to the Warnings and Precautions section for secondary malignancies to note that T-cell malignancies have occurred following treatment with BCMA- and CD19- directed genetically modified autologous T cell immunotherapies. Mature T-cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes.
• Updates to the Patient Counseling Information and the Medication Guide related to the risk of secondary malignancies, including T-cell malignancies.

Patients treated with these products should be monitored life-long for secondary malignancies.

New malignancies should be reported to the product manufacturer and to the FDA’s MedWatch program.

Last Reviewed/Updated: April 19, 2024

“The HeartMate II and 3 are used for both short- and long-term support in adult patients with severe left ventricular heart failure,” the FDA explained in a statement. “It can be used while waiting for a heart transplant, to help the heart recover, or as a permanent solution when a transplant isn’t an option.”

The devices replace the blood-pumping action of the heart’s main pumping chamber, the left ventricle. They divert blood flow from that weakened chamber and propel it into the aorta, where it flows to the rest of the body. However, in rare cases, a type of clot can form from “biological material” that builds up in a particular area of the devices.

“This buildup can obstruct the device, making it less effective in helping the heart pump blood,” the FDA explained. “It can trigger alarms indicating low blood flow and affect the device’s ability to help the heart properly. The accumulation of biological material typically occurs over 2 years or more.” In the worst cases, this kind of obstruction can lead to injury or death, the agency said.

On February 19, Thoratec “sent all affected customers an Urgent Medical Device Correction Letter,” asking them to pay attention to low flow alarms linked to the devices, “as this is the first symptom of significant outflow obstruction,” according to the FDA. If alarms are reported to doctors, they could address the issue by either monitoring the patient closely, implanting a stent to improve blood flow, or replacing the pump.

One study published in 2022 in the Journal of Thoracic and Cardiovascular Surgery showed the blockages occurred in about 3% of patients with the devices, with the likelihood of obstructions rising over time.

Heart specialists are concerned about the issue, because patients in end-stage heart failure have few options if the HeartMate devices are removed from the market.

In the absence of these devices, “we are in trouble,” Francis Pagani, MD, a cardiothoracic surgeon at the University of Michigan, told KFF Health News. “It would be devastating to the patients to not have this option. It’s not a perfect option, no pump ever is, but this is as good as it’s ever been,” said Pagani, who also oversees a proprietary database of HeartMate II and HeartMate 3 implants.

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The Agency is cracking down on the sale of this type of tobacco product in which nicotine is absorbed from a small pouch that is held between the user’s lip and gum, and does not require spitting. The pouches contain nicotine powder or nicotine salts that are chemically synthesized or extracted from tobacco leaf. Additional fillers, such as microcrystalline cellulose, sweeteners, flavors, and preservatives, are also included. 

It has been shown that adolescents are more willing to try a nicotine product if it has been flavored. Survey results revealed candy/dessert and fruit flavors ranked highest in popularity. ZYN nicotine pouches are available in flavors such as Espressino, Black Cherry, Lemon Spritz, and Cucumber Lime, making them more appealing to youth. 

Though data show the use of nicotine pouches among US high school students has remained unchanged in recent years, the FDA has become aware that increased coverage on social media has brought attention to the products, increasing their popularity. Retailers are being warned that the illegal sale of nicotine products to individuals under the age of 21 will be met with monetary penalties if the violations are not corrected promptly.

“There is no excuse for selling tobacco products to any underage person, and FDA will hold retailers accountable for those violations, especially those who continue to do so after being warned,” said Brian King, PhD, MPH, director of FDA’s Center for Tobacco Products.

As of April 12, 2024, 19 people have reported significant side effects linked to counterfeit Botox products or mishandled botulinum toxin in 9 states (Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, and Washington). These adverse events included blurred or double vision, drooping eyelids, difficulty swallowing, dry mouth, slurred speech, constipation, incontinence, shortness of breath, generalized weakness and difficulty lifting one’s head.

Of these 19 patients, 9 were hospitalized and 4 were treated with botulism antitoxin due to concerns over possible spread of botulinum toxin to other parts of the body. All of the affected individuals were females who received the injections in non-health care settings by untrained individuals who purchased the product from unlicensed sources.

The investigation, which includes the Centers for Disease Control and Prevention (CDC), state health departments, and manufacturers, is ongoing. At this time, health care providers are being asked to carefully inspect their product for any signs of counterfeiting before use. The FDA is working with AbbVie, the manufacturer of Botox, to identify and remove suspected counterfeit products from the US drug supply.

The authentic product includes the following features:

• Product descriptions on the outer cartons are either “BOTOX^® COSMETIC / onabotulinumtoxinA / for Injection” or “OnabotulinumtoxinA / BOTOX^® / for injection”;
• Manufacturer identified on outer carton as either “Allergan Aesthetics / An AbbVie Company” or “abbvie”;
• Outer carton and vial both display the active ingredient as “OnabotulinumtoxinA”; and
• Available in 50-, 100-, and 200-unit dose forms.

The counterfeit product can be identified by 1 or more of the following:

• Outer carton and vial contain lot number C3709C3;
• Outer carton displays the active ingredient as “Botulinum Toxin Type A”;
• Outer carton and vial indicate 150-unit doses; and
• Outer carton contains language that is not in English.

Health care providers who suspect systemic botulism should call their health department immediately for consultation and antitoxin release. Additionally, the CDC’s clinical botulism service can be reached at 770-488-7100.

Adverse events related to medication use should be reported to the FDA’s MedWatch program. Consumers who suspect they were administered counterfeit Botox should call the FDA at 800-551-3989 or submit the report here. 

Atovaquone Oral Suspension is a quinone antimicrobial drug indicated for prevention and treatment of Pneumocystis jiroveci pneumonia (PCP) in adults and children 13 years of age and older who cannot tolerate other medicines, such as trimethoprim-sulfamethoxazole.

The recall involves Lot #AW0221A (NDC #50268-086-12, UPC #5026808612) with an expiration date of August 2025. The product was distributed between March 18, 2024 and March 21, 2024.

At this time, the Company has not received any reports of adverse events related to this recall. In immunocompromised individuals, the use of contaminated product could potentially lead to life-threatening infections such as endocarditis and necrotizing soft tissue infections.

Adverse reactions related to this recall should be reported to the Food and Drug Administration’s MedWatch Adverse Event Reporting program.

Vancomycin Hydrochloride for Oral Solution is indicated for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic- associated pseudomembranous colitis caused by C. difficile. 

The 4 recalled lots of Vancomycin Hydrochloride for Oral Solution USP, 250mg/5mL packaged in 80mL, 150mL, or 300mL pack sizes were distributed nationwide to wholesalers and distributors between November 9, 2023 and February 20, 2024. The following lot numbers are included in this recall:

• NDC# 69238-2261-3; Lot# 22613003A; Expiration Date 9/2025; Pack Size 80mL;
• NDC# 69238-2261-7; Lot# 22613004A; Expiration Date 9/2025; Pack Size 150mL;
• NDC# 69238-2261-7; Lot# 22613005A; Expiration Date 9/2025; Pack Size 150mL; and
• NDC# 69238-2261-5; Lot# 22613005B; Expiration Date 9/2025; Pack Size 300mL.

Certain patients, such as those with renal insufficiency, may be at increased risk of adverse events if they inadvertently receive vancomycin at doses that exceed the daily allowance. At this time, there have been no reports of adverse events related to this recall. Adverse reactions or quality issues should be reported to the FDA’s MedWatch program.

Methocarbamol Injection is a central nervous system depressant with sedative and musculoskeletal relaxant properties. It is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions.

The recalled lot, Methocarbamol Injection, USP 1000mg/10mL (100mg/mL); NDC code 55150-223-10; Lot# 3MC23011; Expiration Date November 2026, was distributed nationwide to wholesalers between January 12, 2024 to January 16, 2024. The recall was initiated after a customer discovered white particles floating inside of the vial.

At this time, there have been no reports of adverse events related to this recall. Administration of an injectable product that contains particulate matter can result in local irritation or swelling and potentially serious systemic events (eg, stroke, death).

Adverse reactions and quality issues should be reported to the FDA’s MedWatch program.

The Companies were flagged for marketing the following products:

• TKTX Company: TKTX Numb Maximum Strength Pain Reliever, Mithra+ 10% Lidocaine, TKTX During Procedure Numbing Gel 40% and J-CAIN cream [LIDOCAINE] 29.9%;
• SeeNext Venture, Ltd.: NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30g) and NumbSkin 10.56% Lidocaine Numbing Cream;
• Tattoo Numbing Cream Co.: Signature Tattoo Numbing Cream and Miracle Numb Spray;
• Sky Bank Media, LLC, doing business as Painless Tattoo Co.: Painless Tattoo Numbing Cream and Painless Tattoo Numbing Spray;
• Dermal Source, Inc.: New & Improved Blue Gel, Superior Super Juice, Premium Pro Plus, Five-Star Vasocaine and Maximum Zone 1; and
• Indelicare, doing business as INKEEZE: Ink Eeze Original B Numb Numbing Gel, Ink Eeze B Numb Numbing Spray Black Label and Ink Eeze B Numb Numbing Foam Soap. 

According to the FDA, some of these OTC analgesic products may contain concentrations of lidocaine that are higher than what is permitted, which may put consumers at risk for serious injury, including irregular heartbeat, seizures, and breathing difficulties.  

The FDA states that consumers should not use OTC pain relief products with more than 4% lidocaine on their skin. Moreover, these products should not be applied heavily over large areas of skin or to irritated or broken skin. Consumers should also not wrap skin treated with these products with plastic wrap or other dressings.

“These products pose unacceptable risks to consumers and should not be on the market,” said Jill Furman, JD, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We are committed to using all available tools to stop the sale of these illegal high-risk products.”

Treprostinil is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (WHO Group 1) to diminish symptoms associated with exercise; and for patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The treatment is administered by either subcutaneous or intravenous infusion.

The recalled product has Lot# 57014, with an expiration date of April 2024. It was distributed nationwide between June 16, 2022 and October 17, 2022.

At this time, there have been no reports of adverse events associated with this recall. Administration of an injectable product that contains particulates can result in local adverse reactions (eg, irritation, swelling) and potentially serious systemic events (eg, stroke, death).

Adverse reactions and quality issues should be reported to the FDA’s MedWatch program.

These products are used as lubricant eye drops and are intended to be sterile. The affected products were distributed nationwide to wholesalers, retailers, and via the product distributor, Walmart, CVS, and AACE Pharmaceuticals Inc, and include the following: 

• Equate Lubricant Eye Ointment; 3.5g tube; NDC 79903-026-35 — Lot# A2E01 (Exp Date April 2024); Lot# A2L05 (Exp Date November 2024); Lot# A3B01 (Exp Date January 2025); Lot# A3C01 (Exp Date February 2025); Lot# A3H05 (Exp Date July 2025);
• Equate Stye Lubricant Eye Ointment; 3.5g tube; NDC 79903-028-35 — Lot# A2D08 (Exp Date March 2024); Lot# A2F02 (Exp Date May 2024); Lot# A2I03 (Exp Date August 2024); Lot# A2L03 (Exp Date November 2024); Lot# A2L04 (Exp Date November 2024); Lot# A3C03 (Exp Date February 2025); Lot# A3C05 (Exp Date February 2025); Lot# A3H01 (Exp Date July 2025); Lot# A3H03 (Exp Date July 2025);
• CVS Health Lubricant Eye Ointment; 3.5g tube; NDC 76168-707-35  — Lot# A2F03 (Exp Date May 2024); Lot# A2I02 (Exp Date August 2024); Lot# A2L02 (Exp Date November 2024); Lot# A3C04 (Exp Date February 2025); Lot# A3H04 (Exp Date July 2025); and
• Lubricant PM Ointment; 3.5g tube; NDC 71406-124-35 — Lot# A2G01 (Exp Date June 2024); Lot# A2G02 (Exp Date June 2024); Lot# A3F08 (Exp Date May 2025); Lot# A3F09 (Exp Date May 2025); Lot# A3J17 (Exp Date September 2025); Lot# A3J18 (Exp Date September 2025).

The administration of contaminated eye drops carries a potential risk for eye infections or related harm. Consumers should discontinue use of the affected products immediately. To date, there have been no reports of adverse events related to this recall.

Adverse reactions or quality problems should be reported to the Food and Drug Administration’s MedWatch program.

The Agency is aware that certain sellers of smartwatches and smart rings are claiming that their noninvasive devices measure blood glucose levels without actually piercing the skin. Though some smartwatches are able to directly display data from an FDA-approved continuous glucose monitoring system, the FDA has never cleared a smartwatch or smart ring that can measure blood glucose levels on its own.

Consumers are being warned not to purchase smartwatches or smart rings that claim to measure blood glucose levels directly, as inaccurate blood glucose measurements from these devices can result in errors in medication management for patients with diabetes.

The FDA is working on ensuring that companies that manufacture and sell these products do not continue to illegally market them with unauthorized claims. Updates will be provided as new information becomes available.

The affected product has lot number 234909 with an expiration date of December 2025, and is packaged in boxes containing 1 bottle and 1 dropper, under SKU RUS-02733. Approximately 3800 units are affected by this recall, though 1/5 of these units have already been returned by retailers.

According to the Company, prolonged use of product that contains elevated vitamin D levels may result in vomiting, loss of appetite, increased thirst, frequent urination, and inability to thrive in infants. At this time, there have been no reports of adverse events related to this recall.

Individuals with questions should contact Nordic Naturals at customerservice@nordicnaturals.com or by calling 888-294-7440. Quality issues or adverse events should be reported to the FDA’s MedWatch program.

Insight Pharmaceuticals is recalling 2 lots of TING^® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid due to the presence of benzene.

The issue was identified during a review of samples that showed elevated levels of benzene, a human carcinogen, in the product. The Company noted that the benzene came from the propellant that sprays the product out of the can and is not an ingredient in TING products. The recall is being conducted out of an abundance of caution; there have been no reports of adverse events related to the use of the product thus far.

The affected lots include Lot# 0H50545 (expiration date 7/24; package size 4.5oz) and Lot# 1G50645 (expiration date 6/25; package size 4.5oz). The recalled products were distributed nationwide through a limited number of retailers and online. 

The Company recently recalled 2 lots of TING^® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder because of elevated benzene levels as well.

Consumers that have the affected product should stop use immediately. To obtain a refund, consumers can contact Insight Pharmaceuticals at 800-344-7239, via email at medicalaffairs@prestigebrands.com, or through its website. 

Adverse reactions related to this recall should be reported to the FDA’s MedWatch program, as well as to the Company.

South Moon, Rebright, and FivFivGo eye drops are copycat products of Bausch + Lomb’s Lumify brand eye drops and should not be available in the US, according to a safety alert issued by the Food and Drug Administration (FDA).

Though it is unclear where these products originated, samples of the South Moon and Rebright eye drops were purchased online and tested by the Agency. While Rebright tested negative for contamination, South Moon was found to be contaminated with Burkholderia cepacia complex. 

Additional testing found that the South Moon and Rebright eye drop products both lacked brimonidine tartrate, the active ingredient in Lumify. The Agency could not obtain samples of FivFivGo for testing.

To date, there have been no adverse event reports specifically linked to these products, though the FDA has received reports indicating quality concerns, eye irritation, pain and infection related to a possibly fake Lumify product.

The Agency is warning consumers not to purchase South Moon, Rebright, or FivFivGo eye drops due to the potential risk for eye infection. Adverse events related to these products should be reported to the FDA’s MedWatch reporting program.

Azurity Pharmaceuticals, Inc is recalling 1 lot of Zenzedi^® (dextroamphetamine sulfate) 30mg tablets due to a mislabeled package.

The recall was initiated after a pharmacist from Nebraska reported that a bottle of Zenzedi 30mg tablets contained carbinoxamine maleate tablets. The affected product, Zenzedi (dextroamphetamine sulfate tablets, USP) 30mg tablets; NDC No. 24338-856-03; Lot No. F230169A; Exp. Date 6/2025, was distributed nationwide to wholesalers between August 23, 2023 and November 29, 2023. 

Zenzedi is a schedule II controlled substance indicated for the treatment of attention deficit hyperactivity disorder and narcolepsy. Carbinoxamine maleate is an antihistamine indicated for the symptomatic treatment of allergic and vasomotor rhinitis, allergic conjunctivitis, urticaria, angioedema, reactions to blood, and dermatographism; it is also indicated for use as an adjunct in anaphylaxis.

The Zenzedi 30mg tablet can be identified by its light yellow color and hexagonal shape. The tablet is debossed with “30” on one side and “MIA” on the other side. The carbinoxamine maleate 4mg tablets that were reported by the pharmacist were white round tablets with imprints of “GL” on one side and “211” on the other side.

Due to the sedating effects of carbinoxamine, there is a possibility of functional impairment in patients who unknowingly consume the drug instead of Zenzedi. To date, the Company has not received any reports of serious adverse events related to this recall. 

Any adverse events associated with the recall should be reported to the FDA’s MedWatch program.

Haleon is voluntarily recalling 8 lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult to the consumer level due to microbial contamination.

Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult are cough syrups indicated for the temporary relief of symptoms occurring with cold or flu, hay fever, or other respiratory allergies. 

The following lots have been recalled:

• Robitussin Honey CF Max Day Adult 4oz
  • Lot Number T10810; Expiry Date October 31, 2025
• Robitussin Honey CF Max Day Adult 8oz
  • Lot Number T08730; Expiry Date May 31, 2025
  • Lot Number T08731; Expiry Date May 31, 2025
  • Lot Number T08732; Expiry Date May 31, 2025
  • Lot Number T08733; Expiry Date May 31, 2025
  • Lot Number T10808; Expiry Date September 30, 2025
• Robitussin Honey CF Max NT Adult 8oz
  • Lot Number T08740; Expiry Date June 30, 2026
  • Lot Number T08742; Expiry Date June 30, 2026

To date, the Company has not received any reports of adverse events related to this recall.

Adverse events or quality issues should be reported to the Food and Drug Administration’s MedWatch Adverse Events Reporting program. 

In November 2022, the FDA had issued a safety communication regarding the possibility of severe hypocalcemia with serious outcomes in patients with advanced CKD treated with the osteoporosis drug. The Agency went on to assess this risk in 2 studies using data from the Centers for Medicare & Medicaid Services.

Findings showed treatment with Prolia significantly increased the risk of developing severe hypocalcemia compared with bisphosphonates, especially in patients with advanced CKD. Severe hypocalcemia typically developed 2 to 10 weeks after each injection with Prolia; the greatest risk was observed between week 2 and 5.

The investigation also included 77 cases submitted to the FDA from July 2010 through May 2021. In these reports, patients with CKD (n=25) had experienced complications of severe hypocalcemia (eg, arrhythmias, confusion, seizures, face twitching, muscle spasms or weakness) following treatment with Prolia.

In response to these findings, the FDA has added a Boxed Warning to the prescribing information for Prolia about the increased risk of severe hypocalcemia in patients with advanced CKD, particularly in patients on dialysis or with mineral and bone disorder (MBD). This information has also been added to the patient Medication Guide and to the Prolia Risk Evaluation and Mitigation Strategy (REMS).

The FDA is recommending that health care providers assess their patients’ renal function before prescribing Prolia. The risk of severe hypocalcemia with Prolia treatment should be considered in patients with advanced CKD. If Prolia is still being considered, calcium blood levels should be obtained and these patients should be assessed for CKD-MBD.

To help reduce the risk of severe hypocalcemia, a health care professional with expertise in the diagnosis and management of CKD-MBD should be involved in the decision-making.  Managing CKD-MBD, correcting hypocalcemia and supplementing with calcium and activated vitamin D before and during Prolia treatment may decrease the risk of severe hypocalcemia. Close monitoring of serum calcium and prompt management of severe hypocalcemia is necessary to minimize the risk of complications.

GLP-1 RAs are used in the treatment of type 2 diabetes or for chronic weight management in obese and overweight individuals. The medication class includes dulaglutide, exenatide, liraglutide, lixisenatide. semaglutide, and tirzepatide. 

According to the FDA, a preliminary evaluation of available evidence does not suggest a causal link between these medications and suicidal thoughts or actions. The Agency was prompted to conduct the investigation following reports of suicidal ideation received through the FDA Adverse Event Reporting System. 

A review of these reports coupled with data from clinical trials, including large outcome studies and observational studies, did not demonstrate an association between GLP-1 RAs and the occurrence of suicidal thoughts and actions. However, it was noted that the risk could not be ruled out entirely as the number of events was small in both GLP-1 RA users and the control groups. The Agency stated that it would continue to investigate this issue with additional evaluations, including a meta-analysis of clinical trials across all GLP-1 RA products and an assessment of postmarketing data. 

At this time, the FDA is recommending that health care professionals monitor and advise patients taking GLP-1 RAs to report new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior. Patients should not discontinue treatment without first consulting with their provider. Adverse events should be reported to the FDA’s MedWatch program.

The recalled IV bags were distributed nationwide to hospitals for administration and include the following item numbers: 

• Fentanyl 1000mcg (10mcg/mL) (as Fentanyl Citrate) PF (from API) added to 0.9% Sodium Chloride 100mL IV bag; Item Number F3355.
• Fentanyl 2500mcg (10mcg/mL) (as Fentanyl Citrate) PF (from API) added to 0.9% Sodium Chloride 250mL IV bag; Item Number F3342.
• Phenylephrine HCl 20mg (80mcg/mL) (from FDP) added to 0.9% Sodium Chloride 250mL IV Bag; Item Number F3360.
• Phenylephrine HCl 40mg (160mcg/mL) (from FDP) added to 0.9% Sodium Chloride 250mL IV Bag; Item Number F3352.
• Vancomycin HCl 1.25g PF added to 0.9% Sodium Chloride 250mL IV Bag; Item Number F3206.
• Vancomycin HCl 1.5g PF added to 0.9% Sodium Chloride 250mL IV Bag; Item Number F3208.

Administration of superpotent IV vancomycin, a glycopeptide antibacterial, or fentanyl, an opioid agonist, can lead to potentially life-threatening adverse events. Moreover, the use of recalled IV phenylephrine, an alpha-1 adrenergic receptor agonist, can lead to higher than intended blood pressure increases. To date, the Company has not received any reports of adverse events related to this recall.

The full list of recalled products, including lot numbers and expiration dates, can be found here. 

Adverse events or quality issues should be reported to the Food and Drug Administration’s MedWatch Adverse Event Reporting program. 

Counterfeit Ozempic (semaglutide) injection 1mg has been identified in the US drug supply chain, according to the Food and Drug Administration (FDA).

Wholesalers, retail pharmacies, health care practitioners and patients are being advised not to distribute, use, or sell products labeled with lot number NAR0074 and serial number 430834149057. The Agency has seized thousands of units of the counterfeit product and is currently testing it, along with manufacturer Novo Nordisk.

Analyses completed thus far show that the needles from the seized products are counterfeit, presenting a possible risk of infection for patients who use the product. The counterfeit needles have the following characteristics: 

• The paper tab on the counterfeit needles is imprinted with the Ozempic product carton lot number NAR0074. 
• The inner needle cover has a blue transparent color.
• The paper tab states “NovoFine”.

Additional counterfeit components include the pen label, the health care professional and patient information package insert, and the carton.

To date, the Agency has been notified of 5 adverse events linked to this lot. All of the reported adverse reactions (nausea, vomiting, diarrhea, abdominal pain, constipation) were consistent with the known safety profile of authentic Ozempic. 

Retail pharmacies are being advised to only purchase Ozempic through authorized distributors of Novo Nordisk. The FDA is recommending that patients only obtain Ozempic through state-licensed pharmacies and check the product before using for any signs of counterfeiting.

Adverse events related to the use of this product should be reported to the FDA’s MedWatch program. Retailers and patients may also contact Novo Nordisk customer care at 1-800-727-6500.

Novo Nordisk recently announced that it was pursuing legal proceedings against 2 compounding pharmacies for selling adulterated and misbranded injectable compounded drugs that contain semaglutide. The Company has also filed 12 legal actions against medical spas, weight loss or medical clinics, and other compounding pharmacies producing products claiming to contain semaglutide.