Glycopyrrolate Injection recall: Impurity Out of Spec
Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago, IL 60631. NDC 71288-408-21
Why was Glycopyrrolate Injection 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 #: G0010120, Exp. Date December 2021; G0080520, Exp. Date April 2022; G0090221, G0100221, Exp. Date January 2023
- Product
- Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago, IL 60631. NDC 71288-408-21
- Recalling firm
- Meitheal Pharmaceuticals Inc
- Quantity
- 1,160 ten-pack cartons
- Distribution
- Nationwide within the USA and India
- Recall date
- September 22, 2021
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)