Why it was recalled
Defective Delivery System: Elevated number of units with out of specification results for leak rate.
Product description
Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 22709, NDC 0173-0682-20.
Lot numbers, UPCs & expiration codes
Lot #: 6ZP9848, Exp 03/18; 6ZP0003, 6ZP9944, Exp 04/18.
Where it was sold
Nationwide in the USA 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-0626-2017
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 22, 2017
- FDA report date
- Apr 12, 2017
- Quantity
- 593,088 inhalers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GlaxoSmithKline, LLC
Original FDA data
Every field from FDA enforcement report D-0626-2017, exactly as published.
Show all FDA fields
- City
- Zebulon
- State
- NC
- Status
- Ongoing
- Country
- United States
- Event ID
- 76839
- Address
- 1011 N Arendell Ave
- Code information
- Lot #: 6ZP9848, Exp 03/18; 6ZP0003, 6ZP9944, Exp 04/18.
- Postal code
- 27597-2309
- Report date
- Apr 12, 2017
- Product type
- Drugs
- Recall number
- D-0626-2017
- Classification
- Class II
- Recalling firm
- GlaxoSmithKline, LLC
- Product quantity
- 593,088 inhalers
- Reason for recall
- Defective Delivery System: Elevated number of units with out of specification results for leak rate.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 22709, NDC 0173-0682-20.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Mar 22, 2017
- Initial firm notification
- Telephone
- Center classification date
- Mar 31, 2017