FDA Drug recall D-1246-2022
Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton…
- FDA Drug
- Class II
- terminated
- Published 2022-07-27
On 2022-07-27 the FDA classified a Class II recall of Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton… by Nephron Sterile Compounding Center, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1246-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-06-30 |
| Published | 2022-07-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Nephron Sterile Compounding Center |
| Distribution | US |
Product
Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-935-03
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lots: AS2001A, Exp. 8/2/2022; AS2002A, Exp. 8/17/2022; AS2003A, Exp. 9/3/2022. |
|---|
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-1246-2022%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.