FDA-Drug2024-04-03Class II
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, Bar Code 70004081011
SCA Pharmaceuticals, LLC
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide in the USA
Affected count
7,198 syringes; expanded 1,289 syringes
Manufactured in
755 Rainbow Rd Ste B, N/A, Windsor, CT, United States
Products
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, Bar Code 70004081011
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0415-2024Don't want to check this manually?
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