July 11, 2001One Lot of Capzasin Recalled
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.
Helps relieve muscle and joint pain caused by arthritis, sprains, and
strains. Is also used for nerve pain (neuralgia) that may be caused by shingles or
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
SUB-POTENCY (STABILITY FAILURE AT 12 MONTHS)
Chattem, Inc., Chattanooga, TN
Firm sent recall letters to all of the 'bill to' addresses on June 14, 2001.
FIRM INITIATED RECALL
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.