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.
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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