Recalls / Class III
Class IIID-0005-2023
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.
- Brand name
- Esomeprazole Magnesium
- Generic name
- Esomeprazole Magnesium
- Active ingredient
- Esomeprazole Magnesium
- Route
- Oral
- NDCs
- 63304-734, 63304-735
- FDA application
- ANDA209735
- Affected lot / code info
- Lot AC14304, Exp 12/2022.
Why it was recalled
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 8640 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-06-21
- FDA classified
- 2022-10-06
- Posted by FDA
- 2022-10-05
- Terminated
- 2023-08-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0005-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.