Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only...
FDA Recall #D-0102-2025 — Class III — November 14, 2024
Product Description
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
Reason for Recall
Labeling: Not Elsewhere Classified - Wrong NDC number
Recalling Firm
Zydus Pharmaceuticals (USA) Inc — Pennington, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
4404 packs
Distribution
USA Nationwide.
Code Information
Lot#: M408002, Exp 05/31/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated