Glycopyrrolate Injection — Class II drug recall D-0396-2023
Terminated recall by Accord Healthcare, Inc., reported 2023-03-08, distributed in PR. CGMP Deviations: recalling drug products following an FDA inspection.
| Recall number | D-0396-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accord Healthcare, Inc., Durham, NC, United States |
| Recall initiated | 2023-02-07 |
| Classified | 2023-03-02 |
| Reported by FDA | 2023-03-08 |
| Terminated | 2024-04-22 |
| Distributed | PR |
| Countries outside the US | CA |
| Quantity | 23,814 vials |
| Reason classes | cgmp |
| UPC / GTIN / UDI-DI | 00316729471084, 00316729471633 |
| NDC | 16729-0471, 16729-0471-08, 16729-0471-63, 16729-0472, 16729-0472-08, 16729-0473, 16729-0473-03, 16729-0474, 16729-0474-03, 16729-0474-05 |
| Lot numbers | R2200159, R2200166, R2200436, R2200618, R2201290, R2201324 |
| Expiration dates | 2024-01-31, 2024-04-30, 2024-08-31 |
Product
Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 1 ml vial NDC 16729-471-63 UPC 3 16729 47163 3; 25 x 1 mL carton NDC 16729-471-08 UPC 3 16729 47108 4
Reason for recall
CGMP Deviations: recalling drug products following an FDA inspection.
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-0396-2023. 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.