Reported Mar 24, 2021 · Terminated

Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge…

Breckenridge Pharmaceutical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Breckenridge Pharmaceutical, Inc · 15 Massirio Dr Ste 201 · Berlin, CT · 06037-2352

Is this the product you have?

  • 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
Lot codes and dates
    • Lot # 191659
    • exp. date 05/2021
Amount recalled
3,146 bottles

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Mar 23, 2022 · Data as of Sep 19, 5:07 PM UTC

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