Why it was recalled
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
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.
Lot numbers, UPCs & expiration codes
Lot AC14304, Exp 12/2022.
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0005-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 21, 2022
- FDA report date
- Oct 5, 2022
- Quantity
- 8640 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0005-2023, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90891
- Address
- 2 Independence Way
- Code information
- Lot AC14304, Exp 12/2022.
- Postal code
- 08540-6620
- Report date
- Oct 5, 2022
- Product type
- Drugs
- Recall number
- D-0005-2023
- Classification
- Class III
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 8640 bottles
- Termination date
- Aug 11, 2023
- Reason for recall
- Superpotent Drug: Out of specification for assay at the 12-month timepoint.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 21, 2022
- Initial firm notification
- Letter
- Center classification date
- Oct 6, 2022