FDA recall D-0312-2021

Golden State Medical Supply Inc. · Class II · 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

Reason for recall

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

Distribution

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

Key facts

Status: Terminated
Initiation date: 2021-03-19
Report date: 2021-03-31
Termination date: 2021-07-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Camarillo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0312-2021