HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single Dose Sy...
FDA Recall #D-0215-2021 — Class II — December 17, 2020
Product Description
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
Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recalling Firm
SCA Pharmaceuticals — Windsor, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
428 syringes
Distribution
Product was distributed to hospitals nationwide.
Code Information
Lot # 1220023220, BUD 1/31/2021; 1220023337, BUD 2/2/2021 & 1220023443, BUD 2/22/2021.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated