SCA Pharmaceuticals, LLC recalls PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe
Recalled April 3, 2024 · FDA recall D-0418-2024 · SCA Pharmaceuticals
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
10,017 syringes, expanded 2579 syringes
Sold at
Nationwide in the USA
Description
Lack of Assurance of Sterility
Product
PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0811-12, Bar Code 70004081112.
Manufacturer(s)
SCA Pharmaceuticals, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →