Glycopyrrolate Injection — Class III drug recall D-0250-2021
Terminated recall by Accord Healthcare, Inc., reported 2021-02-17, distributed nationwide. Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
| Recall number | D-0250-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accord Healthcare, Inc., Durham, NC, United States |
| Recall initiated | 2021-01-28 |
| Classified | 2021-02-08 |
| Reported by FDA | 2021-02-17 |
| Terminated | 2022-02-08 |
| Distributed | Nationwide (US) |
| Quantity | 502 cartons |
| Reason classes | labeling |
| NDC | 16729-0471, 16729-0471-08, 16729-0472, 16729-0472-08, 16729-0472-30, 16729-0473, 16729-0473-03, 16729-0474, 16729-0474-03, 16729-0474-05 |
| Lot numbers | M2013645 |
| Expiration dates | 2022-08-20 |
Product
Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India NDC 16729-472-08 (Vial NDC 16729-472-30)
Reason for recall
Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
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-0250-2021. 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.