Reported Jun 25, 2014 · Terminated

Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for:…

Novartis Pharmaceuticals Corp.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Novartis Pharmaceuticals Corp. · 25 Old Mill Rd · Suffern, NY · 10901-4106

Is this the product you have?

  • Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only
  • Manufactured forMerck, Sharpe & Dohne Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889
  • Manufactured byNovartis Pharma AG Basle, Switzerland NDC 0085-1401-01
Lot codes and dates
    • Lot F0067 exp. 06/14
    • F0079 exp. 04/15
Amount recalled
Lot F0067: 45,834 units; Lot F0079: 63,321 units

Where it was sold

  • Nationwide

Why it was recalled

Failed Stability Specification; out of specification result for particle size distribution during stability testing

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Novartis Pharmaceuticals Corp. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 12, 2015 · Data as of Sep 19, 7:17 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.