Drug Enforcement D-0091-2023

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

Status

Completed

Classification

Class II

Report Date

January 4, 2023

Termination Date

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Product Information

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
Product quantity
1237 cartons
Reason for recall
Failed impurities/degradation specifications: Out of specification for unknown impurities.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
AVKARE LLC
Address
615 N 1st St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0091-2023
Event ID
91390
Recall initiation date
December 22, 2022
Center classification date
December 28, 2022
Code info
Lot#: 43313, 43342, Exp 12/2023
More code info
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