Why it was recalled
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Product description
Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709.
Lot numbers, UPCs & expiration codes
1ZP3065, Exp. Oct-12, 1ZP5453, Exp. Dec-12, 1ZP3315, Exp. May-13, 2ZP9974, Exp. Sep-13.
Where it was sold
Nationwide and Puerto Rico.
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-065-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 24, 2012
- FDA report date
- Dec 5, 2012
- Quantity
- 18,676 Aerosol Units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GlaxoSmithKline, LLC.
Original FDA data
Every field from FDA enforcement report D-065-2013, exactly as published.
Show all FDA fields
- City
- Zebulon
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 63707
- Address
- 1011 North Arendell Ave
- Code information
- 1ZP3065, Exp. Oct-12, 1ZP5453, Exp. Dec-12, 1ZP3315, Exp. May-13, 2ZP9974, Exp. Sep-13.
- Postal code
- 27597-1217
- Report date
- Dec 5, 2012
- Product type
- Drugs
- Recall number
- D-065-2013
- Classification
- Class III
- Recalling firm
- GlaxoSmithKline, LLC.
- Product quantity
- 18,676 Aerosol Units
- Termination date
- Sep 11, 2014
- Reason for recall
- Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709.
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- Oct 24, 2012
- Initial firm notification
- Letter
- Center classification date
- Nov 23, 2012