Product: 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.
Reason for recall: Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Recall initiated: 20220621
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated