Why it was recalled
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Product description
Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC 70000-0232-1
Lot numbers, UPCs & expiration codes
BT001594C
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-0026-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 5, 2021
- FDA report date
- Oct 27, 2021
- Quantity
- 8,976 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0026-2022, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88809
- Address
- 107 College Rd E
- Code information
- BT001594C
- Postal code
- 08540-6623
- Report date
- Oct 27, 2021
- Product type
- Drugs
- Recall number
- D-0026-2022
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 8,976 bottles
- Termination date
- Dec 6, 2022
- Reason for recall
- CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC 70000-0232-1
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 5, 2021
- Initial firm notification
- Letter
- Center classification date
- Oct 22, 2021