SCA Pharmaceuticals recalls HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barc
Recalled January 13, 2021 · FDA recall D-0196-2021 · SCA Pharmaceuticals
Hazard
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit · FDA Class II
Units
1,056 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 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barcode 70004030316) and b) 30 mL Single Dose Syringe (barcode 70004030321), Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095
Manufacturer(s)
SCA Pharmaceuticals
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →