SCA Pharmaceuticals, LLC recalls PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe,
Recalled April 3, 2024 · FDA recall D-0416-2024 · SCA Pharmaceuticals
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
1,118 syringes in kits
Sold at
Nationwide in the USA
Description
Lack of Assurance of Sterility
Product
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11-K, Bar Code 70004081011. (same finished product as F078140, but with RFID for KitCheck
Manufacturer(s)
SCA Pharmaceuticals, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →