FDA-Drug2024-04-03Class II

Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0411-59, Bar Code 70004041159

SCA Pharmaceuticals, LLC
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide in the USA
Affected count
1,508 bags; expanded 1,015 bags
Manufactured in
755 Rainbow Rd Ste B, N/A, Windsor, CT, United States
Products
Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0411-59, Bar Code 70004041159

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0412-2024

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