FDA Drug recall D-0917-2023
Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare, Inc
- FDA Drug
- Class II
- terminated
- Published 2023-07-19
On 2023-07-19 the FDA classified a Class II recall of Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare, Inc by Accord Healthcare, citing presence of Particulate Matter: Particulate matter identified as fiber.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0917-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-07-03 |
| Published | 2023-07-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Accord Healthcare |
| Distribution | US |
Product
Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-512-43.
Reason
Presence of Particulate Matter: Particulate matter identified as fiber.
Identifiers
| ndc | 16729-512-05 |
|---|---|
| ndc | 16729-512-43 |
| code_info | Lot #: M2210154 Exp. date 06/2025; M2212575 Exp. date 08/2025 |
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-0917-2023%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.