Advair “Diskus” 100/50 mcg Recall

Important information about a recall of certain lots of Advair 100/50mcg strength in the United States.

Due to an isolated manufacturing issue, a small number of Glaxo SmithKline's (GSK) Advair 'Diskus' 100/50 mcg 60 dose dry powder inhalers have a defect that in some circumstances could mean that a patient would not receive their asthma maintenance medicine. As a result, GSK is contacting health care professionals as well as pharmacies and wholesalers to help ensure that potentially affected products are returned and replaced. Patients should not discontinue use of Advair, but should check the lot numbers and get replacements of any products in these particular lots. Other strengths or pack sizes of Advair Diskus are not affected, and products outside the US are not affected.

Please note that twenty-five lots of the product are affected, as follows:

4ZP2067 4ZP2104 4ZP2201 4ZP2216 4ZP2217 4ZP2229 4ZP2377

4ZP2474 4ZP2475 4ZP2619 4ZP2759 4ZP2807 4ZP2913 4ZP2901

4ZP3041 4ZP3042 4ZP3139 4ZP3244 4ZP3272 4ZP3373 4ZP3444

4ZP3504 4ZP3550 4ZP3631 4ZP3659

Other lots of these products are not affected.

The lot number of each inhaler is printed on the circular label in the center of the Diskus. The lot number also appears on the foil over wrap and on the box. If patients have any difficulty reading the number, they should check with their pharmacist. Patients who identify that their inhaler is from any of these lots should return it to their pharmacist, where they will be issued with a replacement free of charge.

The majority of the inhalers from these lots work in the normal way and patients should continue to use their inhalers until they are able to exchange them.

As always, if the patient's asthma worsens, they should contact their physician immediately. At most approximately 150 out of approximately 410,000 in twenty-five Lots of Advair Diskus 100/50 mcg manufactured at GSK's Zebulon, North Carolina (US) manufacturing facility between 17 March 2004 and 4 May 2004 and distributed in the US from 1 July 2004 until 6 October 2004 may not operate properly as a result of a manufacturing defect. GSK has conducted a thorough investigation and appropriate action has been taken to help prevent this situation from happening again. If patients or healthcare professionals require additional information, they should call the GSK Customer Response Center at 1-888-825-5249 between the hours of 8am and 8pm Eastern Time in the US, Monday through Friday.

Posted October 21, 2004