D-0801-2021 Class III Terminated
FDA drug recall D-0801-2021 was initiated by Meitheal Pharmaceuticals Inc on Sep 3, 2021 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated May 12, 2024). Affected quantity: 1,160 ten-pack cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 22, 2021
- Initiation Date
- Sep 3, 2021
- Termination Date
- May 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,160 ten-pack cartons
Product Description
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 Pattern
Nationwide within the USA and India
Code Information
Lot #: G0010120, Exp. Date December 2021; G0080520, Exp. Date April 2022; G0090221, G0100221, Exp. Date January 2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0801-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026