FDA Drug recall D-0967-2022
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, R…
- FDA Drug
- Class II
- terminated
- Published 2022-06-08
On 2022-06-08 the FDA classified a Class II recall of Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, R… by Nephron Sterile Compounding Center, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0967-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-05-18 |
| Published | 2022-06-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Nephron Sterile Compounding Center |
| Distribution | US |
Product
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-957-10
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lots: PE1115B, PE1115C, Exp. 5/31/2022; PE1122A, Exp. 6/19/2022; PE2004B, PE2004C, Exp. 7/11/2022; PE2011A, PE2011C, Ex…Lots: PE1115B, PE1115C, Exp. 5/31/2022; PE1122A, Exp. 6/19/2022; PE2004B, PE2004C, Exp. 7/11/2022; PE2011A, PE2011C, Exp. 8/22/2022; PE2015A, PE2015B, PE2015C, Exp. 9/5/2022; PE2016A, PE2016B, PE2016C, Exp. 9/13/2022 |
|---|
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-0967-2022%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.