Reported Dec 7, 2016 · Terminated

Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai -…

Ascend Laboratories LLC

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: Ascend Laboratories LLC · 180 Summit Ave Ste 200 · Montvale, NJ · 07645-1722

Is this the product you have?

    • Metformin Hydrochloride Tablets
    • USP 500 mg
    • 1000 tablets
  • Rx Only Manufactured byAlkem Laboratories Ltd., Mumbai - 400 013, India
  • Distributed byAscend Laboratories, LLC, Montvale, NJ NDC 67877-217-10
Lot codes and dates
    • Lot 6121056
    • exp 5/2019
Amount recalled
1739 bottles

Where it was sold

Why it was recalled

Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP

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 Jun 7, 2017 · Data as of Sep 19, 7:10 PM UTC

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