One Lot of Capzasin Recalled

WASHINGTON, DC (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Chattem, Inc., of Chattanooga, TN is recalling certain lot(s) of Capzasin-HP Lotion, 2 fl oz. because of sub-potency.

This is the first public notice of this Class III recall issued by FDA.

PRODUCT AND CODE
Capzasin-HP Lotion, 2 fl oz (59.1 mL), containing the active ingredient-Capsaicin, 0.075%, NDC No. 41167-6505-6. The product is packaged with a touch free applicator and sold (OTC) boxed as individual units.
Lot 00D403, EXP 04/02

RECALL NUMBER
D-243-1

REASON
SUB-POTENCY (STABILITY FAILURE AT 12 MONTHS)

MANUFACTURER/RECALLING FIRM
Chattem, Inc., Chattanooga, TN

RECALLED BY
Firm sent recall letters to all of the 'bill to' addresses on June 14, 2001.

FIRM INITIATED RECALL
Ongoing

DISTRIBUTION
Nationwide

QUANTITY
11,064.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.