Drug 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
D-0246-2026
Product summary
- Event
- Event 98233
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 96,948 packs
- Official record key
drug-enforcement:D-0246-2026
Official wording
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.
Code information: Lot #: 19251311, Exp Date April 2027
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
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.