September 2013 FDA Recall Bupivacaine Hydrochloride by Hospira Inc.
D-66295-001 - Lack of Assurance of Sterility; potential for vial breakage
This Class II drug recall was voluntarily initiated by Hospira Inc. on September 5, 2013 for the product Bupivacaine Hydrochloride. The FDA reported the reason for recall as lack of assurance of sterility; potential for vial breakage. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-66295-001
Lack of Assurance of Sterility; potential for vial breakage
09-05-2013
10-16-2013
187,150 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.
Nationwide and Guam and Abu Dhabi
10-28-2014
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., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045
Batch or Lot Expiration Information
Lot# Lot 17-400-EV* and 17-401-EV * Note: the lot number may be followed by 01
