FDA-Drug2024-04-03Class II

HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-17, Bar Code 7004030317

SCA Pharmaceuticals, LLC
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide in the USA
Affected count
399 syringes
Manufactured in
755 Rainbow Rd Ste B, N/A, Windsor, CT, United States
Products
HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-17, Bar Code 7004030317

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0408-2024

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