FDA-Drug2024-04-03Class II
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, Bar Code 700040081612.
SCA Pharmaceuticals, LLC
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide in the USA
Affected count
3,671 syringes, expanded 1,911 syringes
Manufactured in
755 Rainbow Rd Ste B, N/A, Windsor, CT, United States
Products
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, Bar Code 700040081612.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0420-2024Don't want to check this manually?
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