Multi event Drug Recall Enforcement Report Class III voluntary initiated by SUN PHARMACEUTICAL INDUSTRIES INC, originally initiated on 06-21-2022 for the 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. The product was recalled due to superpotent drug: out of specification for assay at the 12-month timepoint.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0005-2023 | 06-21-2022 | 10-05-2022 | Class III | 8640 bottles | 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. | Superpotent Drug: Out of specification for assay at the 12-month timepoint. | Terminated |
| D-0004-2023 | 06-21-2022 | 10-05-2022 | Class III | 5712 bottles | 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. | Superpotent Drug: Out of specification for assay at the 12-month timepoint. | Terminated |
Recalled Products
