fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, ...
FDA Recall #D-0396-2024 — Class II — November 9, 2023
Product Description
fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0222-30 BAR code 70004022230
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
500 bags
Distribution
Nationwide in the USA
Code Information
Lot #: 1223048351, Exp 11/30/23; 1223048532, Exp 12/07/23
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated