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SafetyAlerts
August 30, 2001

Fluocinolone 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 CODE:
D-290-1, Fluocinolone Acetonide Ointment USP, 0.025%, in 15 gram and 60 gram tubes, distributed under the E. Fougera & Co. label.

CODE:
Lot G018, expiration date January 2003. 15 g tubes: NDC 0168-0064-15, 60 g tubes: NDC 0168-0064-60

REASON:
Lack of Homogeneity Leading to Super-Potency.

MANUFACTURER:
Altana Inc., Hicksville, NY

RECALLED BY:
Altana Inc., Melville, NY, by letter, dated 8/7/01.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide

QUANTITY:
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.

 
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.