Glycopyrrolate Tablets recall: Impurity Out of Spec
Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15
Why was Glycopyrrolate Tablets recalled?
Failed impurities/degradation specifications: Out of specification for unknown impurities.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot#: 43313, 43342, Exp 12/2023
- Product
- Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15
- Recalling firm
- AVKARE LLC
- Quantity
- 1237 cartons
- Distribution
- USA Nationwide
- Recall date
- January 4, 2023
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (drug)