Drug product
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets
D-0102-2025
Product summary
- Event
- Event 95767
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 4404 packs
- Official record key
drug-enforcement:D-0102-2025
Official wording
Reason: Labeling: Not Elsewhere Classified - Wrong NDC number
Code information: Lot#: M408002, Exp 05/31/2026
Distribution pattern: USA Nationwide.
Derived failure modes
-
Labeling or packaging
Labeling: Not Elsewhere Classified - Wrong