BUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag, Preservative Free (Total Dose Bupivaca...
FDA Recall #D-1006-2017 — Class II — July 14, 2017
Product Description
BUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag, Preservative Free (Total Dose Bupivacaine 312.5 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0062-40
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: 20170502@32 BUD: 7/31/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated