Glycopyrrolate Injection — Class III drug recall D-0801-2021
Terminated recall by Meitheal Pharmaceuticals Inc, reported 2021-09-22, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-0801-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Meitheal Pharmaceuticals Inc, Chicago, IL, United States |
| Recall initiated | 2021-09-03 |
| Classified | 2021-09-15 |
| Reported by FDA | 2021-09-22 |
| Terminated | 2024-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | IN |
| Quantity | 1,160 ten |
| Reason classes | specification failure |
| NDC | 71288-0408-21 |
| Lot numbers | G0010120, G0080520, G0090221, G0100221 |
| Expiration dates | 2021-12-20, 2022-04-20, 2023-01-20 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0801-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.