October 2013 FDA Recall Bupivacaine Hydrochloride by Hospira Inc.
D-395-2014 - Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
This Class II drug recall was voluntarily initiated by Hospira Inc. on October 11, 2013 for the product Bupivacaine Hydrochloride. The FDA reported the reason for recall as lack of assurance of sterility; equipment failure led to potential breach in asceptic process.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-395-2014
Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
10-11-2013
01-08-2014
65109 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hospira Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide.
11-10-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.
Batch or Lot Expiration Information
Lot# 32-484-EV, 32-485-EV Exp: 2/2015.
