D-0312-2021 Class II Terminated
FDA drug recall D-0312-2021 was initiated by Golden State Medical Supply Inc. on March 19, 2021 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer The recall status is terminated (terminated July 28, 2021). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- March 31, 2021
- Initiation Date
- March 19, 2021
- Termination Date
- July 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer
Distribution Pattern
Sold to two wholesalers/distributors under government contract located in PA and TX
Code Information
Lot #: GS029673, Exp. Date 5/2021