Why it was recalled
Failed Stability Specification; out of specification result for particle size distribution during stability testing
Product description
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
Lot numbers, UPCs & expiration codes
Lot F0067 exp. 06/14, F0079 exp. 04/15
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1387-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 28, 2014
- FDA report date
- Jun 25, 2014
- Quantity
- Lot F0067: 45,834 units; Lot F0079: 63,321 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novartis Pharmaceuticals Corp.
Original FDA data
Every field from FDA enforcement report D-1387-2014, exactly as published.
Show all FDA fields
- City
- Suffern
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 68282
- Address
- 25 Old Mill Rd
- Code information
- Lot F0067 exp. 06/14, F0079 exp. 04/15
- Postal code
- 10901-4106
- Report date
- Jun 25, 2014
- Product type
- Drugs
- Recall number
- D-1387-2014
- Classification
- Class III
- Recalling firm
- Novartis Pharmaceuticals Corp.
- Product quantity
- Lot F0067: 45,834 units; Lot F0079: 63,321 units
- Termination date
- Feb 12, 2015
- Reason for recall
- Failed Stability Specification; out of specification result for particle size distribution during stability testing
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- May 28, 2014
- Initial firm notification
- Letter
- Center classification date
- Jun 17, 2014