RecallWatchUSA

Home / Recalls / Drugs

SCA Pharmaceuticals, LLC recalls PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only

Recalled April 3, 2024 · FDA recall D-0417-2024 · SCA Pharmaceuticals

Hazard
Lack of Assurance of Sterility · FDA Class II
Units
5,948 syringes, expanded 2,102 syringes
Sold at
Nationwide in the USA

Description

Lack of Assurance of Sterility

Product
PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022.
Manufacturer(s)
SCA Pharmaceuticals, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

SCA Pharmaceuticals, LLC recalls PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only | RecallWatchUSA