Drug product
Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01
D-0239-2026
Product summary
- Event
- Event 98141
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 575 1x10 Foil Blister Packs
- Official record key
drug-enforcement:D-0239-2026
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: J1325J, I1725P, EXP Date: 4/30/2027.
Distribution pattern: Natinowide in the USA
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.