December 2013 FDA Recall Propofol by Hospira Inc.
D-1033-2014 - Presence of Particulate Matter
This Class II drug recall was voluntarily initiated by Hospira Inc. on December 12, 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-1033-2014
Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate matter which could result in the potential for small glass flakes or embedded metal particulate to become dislodged into the solution.
12-12-2013
01-29-2014
126,425 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
10-16-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, packaged in 5 Units x 20 mL per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
Batch or Lot Expiration Information
Lot# : 27-568-DJ*, Exp 03/15, Note * may be followed by 01
