Why it was recalled
Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.
Product description
Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral Inhalation Only, Net Wt. 18 g, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20
Lot numbers, UPCs & expiration codes
Lot #s: 5ZP1708, Exp. 12/2016; 5ZP1951, Exp. 02/2017
Where it was sold
MS and VT
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-0519-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 3, 2015
- FDA report date
- Dec 16, 2015
- Quantity
- 128,704 Inhalers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GlaxoSmithKline, LLC
Original FDA data
Every field from FDA enforcement report D-0519-2016, exactly as published.
Show all FDA fields
- City
- Zebulon
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 72800
- Address
- 1011 N Arendell Ave
- Code information
- Lot #s: 5ZP1708, Exp. 12/2016; 5ZP1951, Exp. 02/2017
- Postal code
- 27597-2309
- Report date
- Dec 16, 2015
- Product type
- Drugs
- Recall number
- D-0519-2016
- Classification
- Class II
- Recalling firm
- GlaxoSmithKline, LLC
- Product quantity
- 128,704 Inhalers
- Termination date
- Oct 25, 2016
- Reason for recall
- Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral Inhalation Only, Net Wt. 18 g, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20
- Distribution pattern
- MS and VT
- Recall initiation date
- Dec 3, 2015
- Initial firm notification
- Letter
- Center classification date
- Dec 9, 2015