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 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation with Advair HFA actuator only, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0715-20.
Lot numbers, UPCs & expiration codes
Lot #: 1ZP2465, Exp Oct-12, 1ZP5224, Exp. Nov-12, 1ZP5455, 1ZP6916, Exp. Dec-12, 1ZP8042, 1ZP9593, Exp Jan-13, 1ZP9900, Exp. Mar-13, 1ZP1134, Exp. Apr-13, 1ZP3190, 2ZP6531, Exp. May-13, 2ZP6924, 2ZP7258, Exp. Jul-13, 2ZP1886, 2ZP9975, 2ZP0027, 2ZP9782, Exp. Sep-13, 2ZP1331, Exp. Oct-13, 2ZP2366, Exp. Nov-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-064-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 24, 2012
- FDA report date
- Dec 5, 2012
- Quantity
- 310,964 Aerosol Units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GlaxoSmithKline, LLC.
Original FDA data
Every field from FDA enforcement report D-064-2013, 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
- Lot #: 1ZP2465, Exp Oct-12, 1ZP5224, Exp. Nov-12, 1ZP5455, 1ZP6916, Exp. Dec-12, 1ZP8042, 1ZP9593, Exp Jan-13, 1ZP9900, Exp. Mar-13, 1ZP1134, Exp. Apr-13, 1ZP3190, 2ZP6531, Exp. May-13, 2ZP6924, 2ZP7258, Exp. Jul-13, 2ZP1886, 2ZP9975, 2ZP0027, 2ZP9782, Exp. Sep-13, 2ZP1331, Exp. Oct-13, 2ZP2366, Exp. Nov-13.
- Postal code
- 27597-1217
- Report date
- Dec 5, 2012
- Product type
- Drugs
- Recall number
- D-064-2013
- Classification
- Class III
- Recalling firm
- GlaxoSmithKline, LLC.
- Product quantity
- 310,964 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 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation with Advair HFA actuator only, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0715-20.
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- Oct 24, 2012
- Initial firm notification
- Letter
- Center classification date
- Nov 23, 2012