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April 4, 2001

FDA First Notice: Prax® Lotion Recalled

Ferndale, MI (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Ferndale Laboratories, Inc. has recalled Prax ® Lotion because of subpotency (at 12 month stability).

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

Prax ® Lotion, (Pramoxine HCL 1%), 15 mL, physician samples.

Recall #D-153-1.

LOT NOS. 57-209A, 58-007, 58-203.

Ferndale Laboratories, Inc., Ferndale, MI.

Manufacturer, by letters on April 2, 1999 and June 16, 1999. Firm-initiated recall *complete.

*Completed recall: FDA states 'completed recall' indicates the company has removed all affected product from store shelves,  it does not necessarily mean this particular product lot, or codes, have been fully accounted for.

United States.

Not provided.

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!

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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.