Drug & medication recalls Moderate risk

AVKARE LLC recalls Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38…

Recall date
December 22, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0091-2023
FDA classification
Class II
Brand / firm
AVKARE LLC
Sold / distributed
USA Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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