April 2015 FDA Recall Bupivacaine Hydrochloride by Hospira Inc.
D-1216-2015 - Presence of Particulate Matter
This Class I drug recall was voluntarily initiated by Hospira Inc. on April 23, 2015 for the product Bupivacaine Hydrochloride. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1216-2015
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
04-23-2015
07-15-2015
150,950 Vials
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide including Guam.
01-26-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.
Batch or Lot Expiration Information
Lot# : 38-515-DK, Expiry: 1 FEB 2016.
