SCA Pharmaceuticals, LLC recalls PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe,
Recalled April 3, 2024 · FDA recall D-0421-2024 · SCA Pharmaceuticals
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
2,427 syringes
Sold at
Nationwide in the USA
Description
Lack of Assurance of Sterility
Product
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12-K, Bar Code 700040081612. (same finished product as F078140, but with RFID for KitCheck compatibility)
Manufacturer(s)
SCA Pharmaceuticals, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →