Brassica Pharma Pvt. Ltd. has issued a voluntary recall of certain lots of Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment, and Lubricant PM Ointment due to lack of sterility assurance.
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.
References:
US Food and Drug Administration. Brassica Pharma Pvt. Ltd. issues voluntary nationwide recall of Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment, Lubricant PM Ointment due to potential lack of sterility. Updated February 26, 2024. Accessed February 27, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/brassica-pharma-pvt-ltd-issues-voluntary-nationwide-recall-equate-lubricant-eye-ointment-equate-stye.
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