Recalls / Class III
Class IIID-0801-2021
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
- Affected lot / code info
- Lot #: G0010120, Exp. Date December 2021; G0080520, Exp. Date April 2022; G0090221, G0100221, Exp. Date January 2023
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Meitheal Pharmaceuticals Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8700 W Bryn Mawr Ave Ste 600, N/A, Chicago, Illinois 60631-3512
Distribution
- Quantity
- 1,160 ten-pack cartons
- Distribution pattern
- Nationwide within the USA and India
Timeline
- Recall initiated
- 2021-09-03
- FDA classified
- 2021-09-15
- Posted by FDA
- 2021-09-22
- Terminated
- 2024-05-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0801-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.