D-0407-2024 Class II Terminated

Recalled by SCA Pharmaceuticals, LLC — Windsor, CT

Recall Details

Product Type
Drugs
Report Date
April 3, 2024
Initiation Date
November 9, 2023
Termination Date
August 27, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,023 syringes

Product Description

HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in the USA

Code Information

Lot#: 1223048801 Exp 12/04/23; 1223049225 Exp 12/21/23; 1223049264 Exp 12/25/23; 1223049291 Exp 12/26/23; 1223049726 exp 01/11/24