SCA Pharmaceuticals recalls PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceutic
Recalled January 13, 2021 · FDA recall D-0216-2021 · SCA Pharmaceuticals
Hazard
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit · FDA Class II
Units
3152 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
PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022
Manufacturer(s)
SCA Pharmaceuticals
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →