Drug recall D-0004-2023
Product
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-734-90.
Reason for recall
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Lots and codes
Lot AC14299, Exp 12/2022
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- 5712 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 21, 2022
- Terminated
- August 11, 2023
Related products
- Esomeprazole Magnesium – drug information
- NDC 63304-734 Esomeprazole magnesium · Esomeprazole Magnesium 20 mg/1 · Sun Pharmaceutical Industries, Inc
- NDC 63304-735 Esomeprazole magnesium · Esomeprazole Magnesium 40 mg/1 · Sun Pharmaceutical Industries, Inc