Glycopyrrolate Tablets recall: Impurity Out of Spec
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
Why was Glycopyrrolate Tablets recalled?
Failed Impurities/Degradation Specifications
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 #: 01421038A1, Exp. Date 05/2023
- Product
- Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
- Recalling firm
- Aurolife Pharma, LLC
- Distribution
- Nationwide within the United States
- Recall date
- June 28, 2023
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)