May 2014 FDA Recall Drug by Novartis Pharmaceuticals Corp.
D-1387-2014 - Failed Stability Specification; out of specification result for particle size distribution during stability testing

This Class III drug recall was voluntarily initiated by Novartis Pharmaceuticals Corp. on May 28, 2014 for the product Drug. The FDA reported the reason for recall as failed stability specification; out of specification result for particle size distribution during stability testing. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1387-2014

Reason for Recall
Failed Stability Specification; out of specification result for particle size distribution during stability testing
Initiated
05-28-2014
Reported
06-25-2014
Quantity
Lot F0067: 45,834 units; Lot F0079: 63,321 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68282
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.
Novartis Pharmaceuticals Corp.
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.
02-12-2015
Product Description About Product Description
Full technical description of the product.
Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for: Merck, Sharpe & Dohne Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, Manufactured by: Novartis Pharma AG Basle, Switzerland NDC 0085-1401-01

Batch or Lot Expiration Information

Lot# Lot F0067 exp. 06/14, F0079 exp. 04/15