August 30, 2001Fluocinolone Acetonide Ointment Recalled
Melville, NY (SafetyAlerts) - The Food and
Drug Administration (FDA) said today that Altana Inc., is recalling
Fluocinolone Acetonide Ointment USP, 0.025%, in 15 gram and 60 gram tubes,
distributed under the E. Fougera & Co. label.
This is the first public notice of
this Class II
recall issued by the FDA.
RECALL NUMBER, PRODUCT AND
D-290-1, Fluocinolone Acetonide Ointment USP, 0.025%, in 15 gram and 60 gram
tubes, distributed under the E. Fougera & Co. label.
Lot G018, expiration date January 2003. 15 g tubes: NDC 0168-0064-15, 60 g
tubes: NDC 0168-0064-60
Lack of Homogeneity Leading to Super-Potency.
Altana Inc., Hicksville, NY
Altana Inc., Melville, NY, by letter, dated 8/7/01.
FIRM INITIATED RECALL:
24,991 - 15 g tubes and 22,740 - 60 g tubes were distributed
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.