April 4, 2001FDA First Notice: Prax® Lotion
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.
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
*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.
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.