FDA-Drug2024-12-11Class III

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

Zydus Pharmaceuticals (USA) Inc
Hazard

Labeling: Not Elsewhere Classified - Wrong NDC number

Sold states
USA Nationwide.
Affected count
4404 packs
Manufactured in
73 Route 31 N, Pennington, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0102-2025

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