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Emergency Injection Recalled
Sterility concerns have prompted Nephron Sterile Compounding Center to voluntarily recall 153,445 syringes containing epinephrine injection, according to the July 27, 2022, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following products, which were distributed throughout the United States:
- epinephrine injection, 0.1 mg/10 mL (10 mcg/mL) syringes, 5 x 10-mL prefilled syringes per carton, 6 x 5 syringe cartons per case (NDC 69374-544-10), from lots EN2001A (Exp. 7/9/22), EN2003A (Exp. 7/18/22), EN2004A (Exp. 8/1/22), and EN2012A (Exp. 9/1/22); and
- epinephrine injection, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10-mL prefilled syringes per carton, 6 x 5 syringe cartons per case (NDC 69374-925-10), from lots EN2007A (Exp. 7/31/22), EN2008A (Exp. 8/18/22), EN2013A (Exp. 9/11/22), and EN2014A (Exp. 10/2/22).
Nephron Sterile Compounding Center initiated the recalls June 30, 2022. The FDA designated them Class II on July 18, 2022, communicating use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Epinephrine is a prescription medicine used to treat life-threatening allergic reactions.