Drug product
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-848-94
D-0443-2025
Product summary
- Event
- Event 96860
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 22,152 30 sachets/carton
- Official record key
drug-enforcement:D-0443-2025
Official wording
Reason: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Code information: Lot #:M402147, Exp 10/2025; M311637, Exp 07/2025; M402495, Exp 02/2026; M407997, Exp 05/2026; M502246, Exp11/2026.
Distribution pattern: Nationwide -in the USA
Derived failure modes
-
Potency or specification failure
Out-of-Specification