D-0091-2023 Class II
FDA drug recall D-0091-2023 was initiated by AVKARE LLC on Dec 22, 2022 and is designated Class II. Reason for recall: Failed impurities/degradation specifications: Out of specification for unknown impurities. Affected quantity: 1237 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 4, 2023
- Initiation Date
- Dec 22, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1237 cartons
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.
Distribution Pattern
USA Nationwide
Code Information
Lot#: 43313, 43342, Exp 12/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0091-2023
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026