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
Reported: March 31, 2021 Initiated: March 19, 2021 #D-0312-2021
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
Details
- Recalling Firm
- Golden State Medical Supply Inc.
- Units Affected
- N/A
- Distribution
- Sold to two wholesalers/distributors under government contract located in PA and TX
- Location
- Camarillo, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Golden State Medical Supply Inc.. Units affected: N/A.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 31, 2021. Severity: Moderate. Recall number: D-0312-2021.
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