Drug 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
D-0801-2021
Product summary
- Event
- Event 88619
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,160 ten-pack cartons
- Official record key
drug-enforcement:D-0801-2021
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: G0010120, Exp. Date December 2021; G0080520, Exp. Date April 2022; G0090221, G0100221, Exp. Date January 2023
Distribution pattern: Nationwide within the USA and India
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications