FDA Drug recall D-0801-2021
Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago, IL 60631
- FDA Drug
- Class III
- terminated
- Published 2021-09-22
On 2021-09-22 the FDA classified a Class III recall of Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago, IL 60631 by Meitheal Pharmaceuticals, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0801-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-09-03 |
| Published | 2021-09-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Meitheal Pharmaceuticals |
| Distribution | US |
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
Failed Impurities/Degradation Specifications
Identifiers
| code_info | Lot #: G0010120, Exp. Date December 2021; G0080520, Exp. Date April 2022; G0090221, G0100221, Exp. Date January 2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0801-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.