Class II · Posted January 7, 2026 · Started December 30, 2025 · Ongoing
ondansetron
- Product
- Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13
- Firm
- Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ
- Reason
- Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
- Lots
- Lot #: 19251311, Exp Date April 2027
- Quantity
- 96,948 packs
- Distribution
- Nationwide within the United States
- RxNorm
- ondansetron (RxCUI 104894, 198052, 312086, 312087)
- Recall number
- D-0246-2026