Drug product
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 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 68382-849-94
D-0442-2025
Product summary
- Event
- Event 96860
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 30,674 30 sachets/carton
- Official record key
drug-enforcement:D-0442-2025
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 # M311638, Exp 07/2025, M400374, Exp 10/2025, M402496, Exp 02/2026, M407998, Exp 05/2026, M502247, Exp 11/2026, M414770, M414512, Exp 09/2026.
Distribution pattern: Nationwide -in the USA
Derived failure modes
-
Potency or specification failure
Out-of-Specification