Breckenridge Pharmaceutical, Inc recalls Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical
Recalled March 24, 2021 · FDA recall D-0308-2021 · Breckenridge Pharmaceutical
Hazard
Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing. · FDA Class II
Units
3,146 bottles
Sold at
Product was distributed nationwide
Description
Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
Product
Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10
Manufacturer(s)
Breckenridge Pharmaceutical, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →