D-0308-2021 Class II Terminated
FDA drug recall D-0308-2021 was initiated by Breckenridge Pharmaceutical, Inc on March 11, 2021 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing. The recall status is terminated (terminated March 23, 2022). Affected quantity: 3,146 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 24, 2021
- Initiation Date
- March 11, 2021
- Termination Date
- March 23, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,146 bottles
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
Distribution Pattern
Product was distributed nationwide
Code Information
Lot # 191659, exp. date 05/2021