D-0406-2024 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
1,425 syringes

Product Description

HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-18, Bar Code 70004030018

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 1223048451 Exp 11/20/23; 1223048923 Exp 12/07/23; 1223049097 Exp 12/15/23; 1223049129 Exp 12/19/23;