FDA-Drug2020-04-08Class II
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
Par Pharmaceutical Inc.
Hazard
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Sold states
Product was distributed within the United States.
Affected count
29,352 bottles
Manufactured in
1 Ram Ridge Rd, N/A, Chestnut Ridge, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1071-2020Don't want to check this manually?
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