fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose...
FDA Recall #D-0402-2024 — Class II — November 9, 2023
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
Recalling Firm
SCA Pharmaceuticals, LLC — Windsor, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1,259 syringes
Distribution
Nationwide in the USA
Code Information
Lot #: 1223048522, Exp 12/07/23; 1223049168, Exp 01/04/24; 1223049552, Exp 01/19/24
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated