Reported Jan 4, 2023 · Completed

Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN…

Avkare 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: AVKARE LLC · 615 N 1st St · Pulaski, TN · 38478-2403

Is this the product you have?

  • Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only
  • Manufactured for
    • AvKARE Pulaski
    • TN 38478
    • NDC 50268-363-15
Lot codes and dates
    • Lot#: 43313
    • 43342
    • Exp 12/2023
Amount recalled
1237 cartons

Where it was sold

  • Nationwide

Why it was recalled

Failed impurities/degradation specifications: Out of specification for unknown impurities.

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, 5:54 PM UTC

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