Urgent: drug recall

January 20, 2012
Re:
Ventolin HFA Inhaler – 60 Actuations – NDC 0173-0682-21
Ventolin HFA Inhaler Sample 60 Actuations - NDC 0173-0682-23
Ventolin HFA Inhaler Institutional Pack 60 Actuations - NDC 0173-0682-24
Ventolin HFA NOVAPLUS 60 Actuations - NDC 0173-0682-54

Dear Customer:
GlaxoSmithKline is recalling the Ventolin HFA Inhaler lots listed below from the retail
level. These lots are being recalled due to the potential that a very low level of canisters
may not contain sufficient propellant to deliver the labeled claim of 60 actuations.
Patients requiring treatment for increased symptoms of bronchospasm (i.e. shortness of
breath, wheezing, chest tightness) but not receiving medication could potentially need to
seek additional medical help.
Product Description
Ventolin HFA Inhaler Sample - 60 Actuations Ventolin HFA Inhaler Sample - 60 Actuations Ventolin HFA Inhaler Sample - 60 Actuations Ventolin HFA Inhaler Sample - 60 Actuations Ventolin HFA Inhaler Sample - 60 Actuations Ventolin HFA Inhaler Institutional Pack – 60 Actuations 0173-0682-24 1ZP0856 Ventolin HFA Inhaler Institutional Pack – 60 Actuations 0173-0682-24 1ZP1981 Ventolin HFA Inhaler Institutional Pack – 60 Actuations 0173-0682-24 1ZP6941 Ventolin HFA Inhaler Institutional Pack – 60 Actuations 0173-0682-24 1ZP7824 Ventolin HFA Inhaler Institutional Pack – 60 Actuations 0173-0682-24 1ZP9063 Ventolin HFA NOVAPLUS – 60 Actuations Recalled product was shipped between September 23, 2011 and January 10, 2012. Stop distributing and immediately quarantine all listed Ventolin HFA Inhaler lots. Please
pick up all remaining inventory at the pharmacy level and provide the
corresponding credit. Please carry out a physical count and record this data on the
business reply form and the packing slip which are included with this letter and send it
to GSK PR Customer Service Department at 787-774-1719. Please examine your
inventory immediately and return all units of the listed Ventolin HFA Inhaler lots to
GlaxoSmithKline Puerto Rico. It is very important that you complete the requested
information on the enclosed Business Reply Form and return it to us within five (5)
business days, even if you do not have the listed Ventolin HFA Inhaler lots in
stock.

Thank you for your cooperation. For shipping assistance or questions about the
withdrawal process, please contact GSK PR, Customer Service Department at
787-774-1600 extensions 4991, 4990 and 2068. Reimbursement will be issued at
current WAC price. These special instructions apply to GSK PR Customers.
This recall is being conducted with the knowledge of the U.S. Food and Drug
Administration.
We appreciate your immediate attention and cooperation. GlaxoSmithKline remains
committed to product quality, integrity, and patient satisfaction and we sincerely regret
any inconvenience this action may cause.

Source: http://pharmacyservices.utah.edu/alerts/alert-618-b.pdf