fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL B...
FDA Recall #D-0395-2024 — Class II — November 9, 2023
Product Description
fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, 877.550.5059, NDC 70004-0229-40 BAR code 70004022940
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
548 bags
Distribution
Nationwide in the USA
Code Information
Lot #: 1223045757, Exp 12/27/23; 1223049716, Exp 5/25/24
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated