Reported Dec 28, 2022 · Ongoing

Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ…

Aurolife Pharma, 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: Aurolife Pharma, LLC · 2400 US Highway 130 · Dayton, NJ · 08810-1519

Is this the product you have?

  • Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only
  • Distributed byAurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
Lot codes and dates
  • Lots01422002A1
  • Expiry
    • 12/2023
    • 01421078A3
  • Expiry09/2023
Amount recalled
7344 bottles

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Failed Impurities/Degradation Specifications

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

Data as of Sep 19, 5:55 PM UTC

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