Drug product
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
D-0227-2026
Product summary
- Event
- Event 97936
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 52,128 bottles
- Official record key
drug-enforcement:D-0227-2026
Official wording
Reason: Defective container - seal not adhering to bottles
Code information: Lot # QB00865, exp. date Feb 2028
Distribution pattern: Nationwide.
Derived failure modes
-
Unknown
Defective container - seal not adhering to bottles