FDA Drug · D-0308-2021

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

Class II · Terminated

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

Affected lots / codes — check yours against thisLot # 191659, exp. date 05/2021

Recalling firm: Breckenridge Pharmaceutical, Inc, Berlin, CT
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 3,146 bottles
Distribution: Product was distributed nationwide
Recall initiated: March 11, 2021
Classified: March 18, 2021
Terminated: March 23, 2022
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0308-2021%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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