FDA recall D-0091-2023

AVKARE LLC · Class II · drug

Product

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

Reason for recall

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

Distribution

USA Nationwide

Key facts

Status
Completed
Initiation date
2022-12-22
Report date
2023-01-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pulaski, TN, United States

Primary source

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