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SCA Pharmaceuticals, LLC recalls PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syrin

Recalled April 3, 2024 · FDA recall D-0414-2024 · SCA Pharmaceuticals

Hazard
Lack of Assurance of Sterility · FDA Class II
Units
33,072 syringes; expanded 9,041 syringes
Sold at
Nationwide in the USA

Description

Lack of Assurance of Sterility

Product
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-12, Bar Code 70004081012
Manufacturer(s)
SCA Pharmaceuticals, LLC

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

SCA Pharmaceuticals, LLC recalls PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syrin | RecallWatchUSA