FDA-Drug2023-01-04Class II

Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15

AVKARE LLC
Hazard

Failed impurities/degradation specifications: Out of specification for unknown impurities.

Sold states
USA Nationwide
Affected count
1237 cartons
Manufactured in
615 N 1st St, Pulaski, TN, United States
Products
Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0091-2023

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