Why it was recalled
Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
Product description
Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with Ventolin HFA actuator only. Net. wt. 18 g Rx only, GlaxoSmithKline, Reasearch Triangle Park, NC 27709 NDC 0173-0682-20
Lot numbers, UPCs & expiration codes
Lot 1ZP7355 Exp. 01/13, 1ZP7749 Exp. 01/13, 1ZP8141 Exp. 01/13, 1ZP8147 Exp. 01/13, 1ZP7729 Exp. 01/13, 1ZP0414 Exp. 03/13, 1ZP0464 Exp. 03/13, 1ZP0570 Exp. 03/13, 1ZP0576 Exp. 03/13, 1ZP0919 Exp. 03/13, 2ZP4959 Exp. 04/13, 2ZP4966 Exp. 04/13
Where it was sold
Nationwide
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-1666-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 26, 2012
- FDA report date
- Sep 5, 2012
- Quantity
- 1,412,566 inhalers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GlaxoSmithKline Inc
Original FDA data
Every field from FDA enforcement report D-1666-2012, exactly as published.
Show all FDA fields
- City
- Zebulon
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 62799
- Address
- 1011 North Arendell Ave
- Address (line 2)
- P.O. Box 1217
- Code information
- Lot 1ZP7355 Exp. 01/13, 1ZP7749 Exp. 01/13, 1ZP8141 Exp. 01/13, 1ZP8147 Exp. 01/13, 1ZP7729 Exp. 01/13, 1ZP0414 Exp. 03/13, 1ZP0464 Exp. 03/13, 1ZP0570 Exp. 03/13, 1ZP0576 Exp. 03/13, 1ZP0919 Exp. 03/13, 2ZP4959 Exp. 04/13, 2ZP4966 Exp. 04/13
- Postal code
- 27597-1217
- Report date
- Sep 5, 2012
- Product type
- Drugs
- Recall number
- D-1666-2012
- Classification
- Class II
- Recalling firm
- GlaxoSmithKline Inc
- Product quantity
- 1,412,566 inhalers
- Termination date
- Sep 4, 2014
- Reason for recall
- Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with Ventolin HFA actuator only. Net. wt. 18 g Rx only, GlaxoSmithKline, Reasearch Triangle Park, NC 27709 NDC 0173-0682-20
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 26, 2012
- Initial firm notification
- Letter
- Center classification date
- Aug 28, 2012