Class II
Terminated
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
- Company
- Breckenridge Pharmaceutical, Inc
- Recall Initiated
- March 11, 2021
- Posted
- March 24, 2021
- Recall Number
- D-0308-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3,146 bottles
- Firm Location
- Berlin, CT, United States
Reason for Recall
Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
Distribution
Product was distributed nationwide
Lot / Code Info
Lot # 191659, exp. date 05/2021
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