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.
Reported: October 5, 2022 Initiated: June 21, 2022 #D-0005-2023
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.
Details
- Recalling Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Units Affected
- 8640 bottles
- Distribution
- Nationwide in the USA
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 8640 bottles.
Why was this product recalled? ▼
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 5, 2022. Severity: Low. Recall number: D-0005-2023.
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