FDA recall D-0801-2021
Meitheal Pharmaceuticals Inc · Class III · 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
Reason for recall
Failed Impurities/Degradation Specifications
Distribution
Nationwide within the USA and India
Key facts
- Status
- Terminated
- Initiation date
- 2021-09-03
- Report date
- 2021-09-22
- Termination date
- 2024-05-12
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Chicago, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0801-2021