February 2013 FDA Recall Propofol by Hospira Inc.
D-223-2013 - Presence of Particulate Matter

This Class II drug recall was voluntarily initiated by Hospira Inc. on February 25, 2013 for the product Propofol. 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-223-2013

Reason for Recall
Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.
Initiated
02-25-2013
Reported
04-03-2013
Quantity
68,020 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64719
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-08-2014
Product Description About Product Description
Full technical description of the product.
Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials per carton, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 10 x 100 mL Single patient infusion vials per carton, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA.

Batch or Lot Expiration Information

Lot# a)
Lot# : 06-804-DJ*, Exp 1JUN2013; and b)
Lot# : 05-736-DJ*, Exp 1MAY2013; 09-066-DJ*, Exp 1SEP2013. *Note: the lot number may be followed by 01 or 02.

Affected Packages Involved in this Recall

0409-4699-50 Propofol
0409-4699-30 Propofol
0409-4699-53 Propofol
0409-4699-33 Propofol
0409-4699-54 Propofol
0409-4699-24 Propofol
0409-6010-02 Propofol
0409-6010-25 Propofol