Recalls / Class II
Class IID-0026-2022
Product
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
- Brand name
- Acid Reducer
- Generic name
- Omeprazole Magnesium
- Active ingredient
- Omeprazole Magnesium
- Route
- Oral
- NDC
- 70000-0232
- FDA application
- ANDA078878
- Affected lot / code info
- BT001594C
Why it was recalled
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- LEADER/ Cardinal Health 110, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 8,976 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2021-10-05
- FDA classified
- 2021-10-22
- Posted by FDA
- 2021-10-27
- Terminated
- 2022-12-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0026-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.