Recalls / Class II
Class IID-0308-2021
Product
Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10
- Affected lot / code info
- Lot # 191659, exp. date 05/2021
Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
Recalling firm
- Firm
- Breckenridge Pharmaceutical, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 15 Massirio Dr Ste 201, N/A, Berlin, Connecticut 06037-2352
Distribution
- Quantity
- 3,146 bottles
- Distribution pattern
- Product was distributed nationwide
Timeline
- Recall initiated
- 2021-03-11
- FDA classified
- 2021-03-18
- Posted by FDA
- 2021-03-24
- Terminated
- 2022-03-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0308-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.