Drug 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

D-0312-2021

March 19, 2021

Class II

Product summary

Firm: Golden State Medical Supply Inc.
Event: Event 87566
Status: Terminated
Classification: Class II
Quantity: N/A
Official record key: drug-enforcement:D-0312-2021

Official wording

Reason: Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer

Code information: Lot #: GS029673, Exp. Date 5/2021

Distribution pattern: Sold to two wholesalers/distributors under government contract located in PA and TX

Derived failure modes

Potency or specification failure
reason.potency_specification_failure · v1.0.0

Out of Specification