BUPIVacaine HCl 0.2% IN 0.9% Sodium Chloride 250 mL Bag Preservative Free (Total Dose Bupivacaine...
FDA Recall #D-1007-2017 — Class II — July 14, 2017
Product Description
BUPIVacaine HCl 0.2% IN 0.9% Sodium Chloride 250 mL Bag Preservative Free (Total Dose Bupivacaine 500 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0066-40
Reason for Recall
Lack of Assurance of Sterility; product has the potential to leak.
Recalling Firm
SCA Pharmaceuticals — Little Rock, AR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
Nationwide
Code Information
Lot: 20170501@69 BUD: 7/30/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated