Nephron Sterile Compounding Center LLC — Class II Recall

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

Classification

Class II

Status

Terminated

Lot

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

Date

2022-07-27

Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.