Safety Alerts Saves Lives
Safety Alerts  
 
Home Privacy About Us Contact Us Change Preferences

spacer.gif (43 bytes)

FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
August 5, 1998

PRODUCT
Triamcinolone Acetonide Cream USP, 0.5%, in 15 gram tubes, Rx topical corticosteroid. NDC #49158-141-20. Recall #D-210-8.

CODE
Lot numbers: M267 EXP 1/2002, K910 EXP 6/2001.

MANUFACTURER
Thames Pharmacal Company, Ronkonkoma, New York.

RECALLED BY
Manufacturer, by letter faxed on July 2, 1998, followed by telephone. Firm-initiated recall ongoing.

DISTRIBUTION
New York, California, Colorado, Florida, Indiana, Michigan, Ohio, Texas, Puerto Rico.

QUANTITY
28,116 units of lot M267 and 1,641 units of lot K910 were distributed.

REASON
Mispackaging - Some tubes of 0.1% cream were packaged into cartons labeled as 0.5%.

 

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.