January 2013 FDA Recall Drug by Actelion Pharmaceuticals U.s., Inc.
D-143-2013 - Subpotent Drug

This Class III drug recall was voluntarily initiated by Actelion Pharmaceuticals U.s., Inc. on January 16, 2013 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed in CA & VA and the recall is currently terminated.

Recall Number: D-143-2013

Reason for Recall
Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.
Initiated
01-16-2013
Reported
02-13-2013
Quantity
3 Cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64151
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Actelion Pharmaceuticals U.S., 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.
CA & VA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2013
Product Description About Product Description
Full technical description of the product.
Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton, Manufactured for Actelion Pharmaceuticals US, Inc, 5000 Shoreline Court, Ste 200, South San Francisco, CA 94080, NDC: 66215-302-30.

Batch or Lot Expiration Information

Lot# : MA00AD5, Exp: 11/30/2014