EPI Health Recalls Drug Products Due to Company Shutdown

EPI Health has initiated a voluntary recall of various within-expiry drug products as the Company has shut down operations and is unable to assure the quality of the products.

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.