Reported Apr 8, 2020 · Terminated

Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977,…

Par 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: Par Pharmaceutical Inc. · 1 Ram Ridge Rd · Chestnut Ridge, NY · 10977-6714

Is this the product you have?

  • Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist
  • byPar Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg
  • by
    • Par Formulations Private Limited
    • 1/58
    • Pudupakkam
    • Kelambakkam - 603 103
    • Made in India NDC# 49884-0065-01
Lot codes and dates
    • Lot # 32809101
    • Exp 3/2021
Amount recalled
29,352 bottles

Why it was recalled

Failed Impurities/Degradation Specification: Presence of unknown impurity observed.

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 Nov 2, 2021 · Data as of Sep 19, 5:03 PM UTC

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