D-0005-2023 Class III Terminated
FDA drug recall D-0005-2023 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on Jun 21, 2022 and is designated Class III. Reason for recall: Superpotent Drug: Out of specification for assay at the 12-month timepoint. The recall status is terminated (terminated Aug 11, 2023). Affected quantity: 8640 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 5, 2022
- Initiation Date
- Jun 21, 2022
- Termination Date
- Aug 11, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8640 bottles
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot AC14304, Exp 12/2022.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0005-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026