Recalls / Class II
Class IID-0312-2021
Product
Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA, NDC 51407-129-10
- Affected lot / code info
- Lot #: GS029673, Exp. Date 5/2021
Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer
Recalling firm
- Firm
- Golden State Medical Supply Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5187 Camino Ruiz, N/A, Camarillo, California 93012-8601
Distribution
- Quantity
- N/A
- Distribution pattern
- Sold to two wholesalers/distributors under government contract located in PA and TX
Timeline
- Recall initiated
- 2021-03-19
- FDA classified
- 2021-03-24
- Posted by FDA
- 2021-03-31
- Terminated
- 2021-07-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0312-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.