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SafetyAlerts
July 11, 2001

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.

Capzasin-HP
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 diabetic neuropathy

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.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.