🔍 RecallPedia

Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889. Manufactured by: Novartis Pharma AG Basle,Via Serafino Balestra 31 Locarno, Switzerland.

Class I - Dangerous
💊 Drugs Recalled: May 22, 2015 Novartis Pharmaceuticals Prescription Drugs

What Should You Do?

  1. Check if you have this product:
    Lot #: F8011, Exp May 2015
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Novartis Pharmaceuticals Corp.
Reason for Recall:
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889. Manufactured by: Novartis Pharma AG Basle,Via Serafino Balestra 31 Locarno, Switzerland.

Product Codes/Lot Numbers:

Lot #: F8011, Exp May 2015

Distribution:

Distributed in: NJ

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1137-2015

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