Class III
Terminated
Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, 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 63304-735-90.
- Recall Initiated
- June 21, 2022
- Posted
- October 5, 2022
- Recall Number
- D-0005-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 8640 bottles
- Firm Location
- Princeton, NJ, United States
Reason for Recall
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Distribution
Nationwide in the USA
Lot / Code Info
Lot AC14304, Exp 12/2022.
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