fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0...
FDA Recall #D-0062-2018 — Class II — October 19, 2017
Product Description
fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205. NDC 70004-0231-40
Reason for Recall
Lack Of Assurance Of Sterility.
Recalling Firm
SCA Pharmaceuticals, LLC — Little Rock, AR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
116 bags
Distribution
Nationwide in the United States
Code Information
Lot: 20170814@20 BUD: 11/12/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated