FDAHealthNovember 14, 2024
Zydus Pharmaceuticals (USA) Inc — Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distribu
⚠️ Labeling: Not Elsewhere Classified - Wrong NDC number
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 14, 2024
USA Nationwide.
What's affected?
- 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
- Lot code
- M408002
Additional details
Lot#: M408002, Exp 05/31/2026
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 4404 packs.
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