Par Pharmaceutical Inc. recalls Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U…
- Recall date
- March 30, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1071-2020
- FDA classification
- Class II
- Brand / firm
- Par Pharmaceutical Inc.
- Sold / distributed
- Product was distributed within the United States.
Why it was recalled
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par 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
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