notyard
10-01-2009, 02:57 PM
FDA class II recall:
PRODUCT
Advair Diskus 100/50mcg (fluticasone propionate/salmeterol inhalation powder, 100/50mcg), Rx only, NDC 0173-0695-00. Product Order Number: 01730695009. Recall # D-1972-2009
CODE
Lot number: 9ZP7632, Expiration Date: April 2010
RECALLING FIRM/MANUFACTURER
GlaxoSmithKline, Inc., Zebulon, NC, by letter on/about August 4, 2009. Firm initiated recall is ongoing.
REASON
Defective delivery system; There is a potential for the foil strip of the inhaler to tear rather than to peel back, which can result in medication not being available to the user as they advance doses through the Diskus unit.
VOLUME OF PRODUCT IN COMMERCE
23,932 units
DISTRIBUTION
Nationwide
PRODUCT
Advair Diskus 100/50mcg (fluticasone propionate/salmeterol inhalation powder, 100/50mcg), Rx only, NDC 0173-0695-00. Product Order Number: 01730695009. Recall # D-1972-2009
CODE
Lot number: 9ZP7632, Expiration Date: April 2010
RECALLING FIRM/MANUFACTURER
GlaxoSmithKline, Inc., Zebulon, NC, by letter on/about August 4, 2009. Firm initiated recall is ongoing.
REASON
Defective delivery system; There is a potential for the foil strip of the inhaler to tear rather than to peel back, which can result in medication not being available to the user as they advance doses through the Diskus unit.
VOLUME OF PRODUCT IN COMMERCE
23,932 units
DISTRIBUTION
Nationwide