April 01, 2021
Out-of-specification results for unknown impurities during testing have prompted Golden State Medical Supply Inc. to recall a single lot of omeprazole delayed-release capsules, according to the March 31, 2021, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects omeprazole delayed-release capsules, 20 mg, 1000-count bottles (NDC 51407-129-10), from lot GS029673 (Exp. 5/21). The capsules were packaged by Golden State Medical Supply, Camarillo, CA, and sold to two wholesalers/distributors under government contract in Pennsylvania and Texas.
Golden State Medical Supply voluntarily initiated the recall March 19, 2021. On March 24, 2021, the FDA designated the recall Class II, signaling use of the capsules could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Omeprazole 20-mg capsules are available with a prescription for the treatment of patients with certain stomach and esophagus problems, such as acid reflux and ulcers.