Recall: D-0091-2023

Class II - Potentially Harmful

Class IIClassification

2022-12-22Initiated

CompletedStatus

AVKARE LLCFirm

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

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

Distribution

USA Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.