Breckenridge Pharmaceutical, Inc: Drug Recall

Recall #D-0308-2021 · 03/11/2021

Class II: Risk

Recall Details

Recall Number: D-0308-2021
Classification: Class II
Product Type: Drug
Recalling Firm: Breckenridge Pharmaceutical, Inc
Status: Terminated
Date Initiated: 03/11/2021
Location: Berlin, CT, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,146 bottles

Reason for Recall

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

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

Distribution Pattern

Product was distributed nationwide

Other Recalls by Breckenridge Pharmaceutical, Inc

Class II: Risk 11/24/2025

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II: Risk 11/24/2025

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II: Risk 10/09/2025

CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Class II: Risk 08/08/2025

CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Class II: Risk 07/25/2025

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

View all recalls by Breckenridge Pharmaceutical, Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.