Drug 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.
D-0004-2023
Product summary
- Event
- Event 90891
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5712 bottles
- Official record key
drug-enforcement:D-0004-2023
Official wording
Reason: Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Code information: Lot AC14299, Exp 12/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Superpotent