D-0402-2024 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
1,259 syringes

Product Description

fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by SCA Pharma. SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0200-17, Bar code 70004020017

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 1223048522, Exp 12/07/23; 1223049168, Exp 01/04/24; 1223049552, Exp 01/19/24