D-0410-2024 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
909 syringes

Product Description

HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-21, Bar Code 70004030321

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in the USA

Code Information

Lot#: 1223048258 Exp 11/10/23; 1223048890 Exp 12/07/23; 1223049134 Exp 12/19/23