FDA-Drug2024-04-03Class II

HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-63, Bar Code 70004030063

SCA Pharmaceuticals, LLC
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide in the USA
Affected count
256 cassettes
Manufactured in
755 Rainbow Rd Ste B, N/A, Windsor, CT, United States
Products
HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-63, Bar Code 70004030063

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0404-2024

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