FDA-Drug2022-12-28Class II

Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01

Aurolife Pharma, LLC
Hazard

Failed Impurities/Degradation Specifications

Sold states
Nationwide in the USA and Puerto Rico.
Affected count
7344 bottles
Manufactured in
2400 US Highway 130, Dayton, NJ, United States
Products
Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0087-2023

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