SCA Pharmaceuticals recalls HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single Dose Syringe, SCA Pharmaceutic
Recalled January 13, 2021 · FDA recall D-0215-2021 · SCA Pharmaceuticals
Hazard
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit · FDA Class II
Units
428 syringes
Sold at
Product was distributed to hospitals nationwide.
Description
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product
HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004030022
Manufacturer(s)
SCA Pharmaceuticals
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →