Par Pharmaceutical Inc. recalls Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.
Recalled April 8, 2020 · FDA recall D-1071-2020 · Par Pharmaceutical
Hazard
Failed Impurities/Degradation Specification: Presence of unknown impurity observed. · FDA Class II
Units
29,352 bottles
Sold at
Product was distributed within the United States.
Description
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Product
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
Manufacturer(s)
Par Pharmaceutical Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →