Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for:...
FDA Recall #D-0091-2023 — Class II — December 22, 2022
Product Description
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.
Recalling Firm
AVKARE LLC — Pulaski, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1237 cartons
Distribution
USA Nationwide
Code Information
Lot#: 43313, 43342, Exp 12/2023
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated