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.

Recall Number: D-0004-2023

Firm: SUN PHARMACEUTICAL INDUSTRIES INC

Classification: Class III

Status: Terminated

Report Date: 20221005

Initiation Date: 20220621

Termination Date: 20230811

Superpotent Drug: Out of specification for assay at the 12-month timepoint.

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.