D-0312-2021 Class II Terminated
FDA drug recall D-0312-2021 was initiated by Golden State Medical Supply Inc. on Mar 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 Jul 28, 2021).
Recall details
- Product Type
- Drugs
- Report Date
- Mar 31, 2021
- Initiation Date
- Mar 19, 2021
- Termination Date
- Jul 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0312-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026