D-0004-2023 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 5, 2022
- Initiation Date
- June 21, 2022
- Termination Date
- August 11, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5712 bottles
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot AC14299, Exp 12/2022