Reported Oct 5, 2022 · Terminated
Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm…
Sun Pharmaceutical Industries Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620
Is this the product you have?
- Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle
- Manufactured byOhm Laboratories Inc. New Brunswick, NJ 08901
- Distributed bySun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-735-90
- Lot codes and dates
Lot AC14304Exp 12/2022
- Amount recalled
- 8640 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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