Why it was recalled
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Product 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.
Lot numbers, UPCs & expiration codes
Lot #: F8011, Exp May 2015
Where it was sold
NJ via 1 distributor
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-1137-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 22, 2015
- FDA report date
- Jun 24, 2015
- Quantity
- 19,658 packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novartis Pharmaceuticals Corp.
Original FDA data
Every field from FDA enforcement report D-1137-2015, exactly as published.
Show all FDA fields
- City
- Suffern
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 71310
- Address
- 25 Old Mill Rd
- Code information
- Lot #: F8011, Exp May 2015
- Postal code
- 10901-4106
- Report date
- Jun 24, 2015
- Product type
- Drugs
- Recall number
- D-1137-2015
- Classification
- Class III
- Recalling firm
- Novartis Pharmaceuticals Corp.
- Product quantity
- 19,658 packs
- Termination date
- May 18, 2016
- Reason for recall
- Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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.
- Distribution pattern
- NJ via 1 distributor
- Recall initiation date
- May 22, 2015
- Initial firm notification
- Letter
- Center classification date
- Jun 15, 2015