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-K, Bar Code 70004081011. (same finished product as F078140, but with RFID for KitCheck
SCA Pharmaceuticals, LLC
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide in the USA
Affected count
1,118 syringes in kits
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-K, Bar Code 70004081011. (same finished product as F078140, but with RFID for KitCheck
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0416-2024Don't want to check this manually?
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