FDA Drug recall D-1276-2022
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Cart…
- FDA Drug
- Class II
- terminated
- Published 2022-07-27
On 2022-07-27 the FDA classified a Class II recall of Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Cart… by Nephron Sterile Compounding Center, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1276-2022 |
| 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
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, 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: PE2004A, Exp. 7/11/2022; PE2008A, Exp. 7/22/2022; PE2008B, Exp. 7/22/2022; PE2008C, Exp. 7/22/2022; PE2009A, Exp.…Lots: PE2004A, Exp. 7/11/2022; PE2008A, Exp. 7/22/2022; PE2008B, Exp. 7/22/2022; PE2008C, Exp. 7/22/2022; PE2009A, Exp. 8/5/2022; PE2009B, Exp. 8/5/2022; PE2009C, Exp. 8/5/2022; PE2011B, Exp. 8/22/2022; PE2017C, Exp. 9/14/2022; PE2019B, Exp. 4/11/2023; PE2019C, Exp. 4/11/2023 |
|---|
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-1276-2022%22
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