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SafetyAlerts
April 12, 2001

Thames Pharmacal Co. Inc. Recalls Fluocinolone Acetonide Solution

Ronkonkoma, NY (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Thames Pharmacal Co., Inc. has recalled certain Fluocinolone Acetonide Solution because of subpotency (12th month stability).

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

PRODUCT
(Rx)Fluocinolone Acetonide Solution, USP, 0.01%, 20 and 60 mL units.

Recall #D-160-1.

CODE:
LOT NO. N133, Exp. Date 12/01.

MANUFACTURER:
Thames Pharmacal Co., Inc., Ronkonkoma, NY.

RECALLED BY:
Manufacturer, by letter on 3/22/01. Firm-initiated recall ongoing.

DISTRIBUTION:
KY, FL, GA, NY, IL, MI, LA, AL, MO, WI, CA, TX, PA, MN, OH, and Puerto Rico.

QUANTITY:
7,007 units of the 20 mL bottles and 3,450 units of the 60 mL bottles.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

Notice of this product warning was sent via email to SafetyAlerts subscribers April 12, 2001.  For more information regarding the SafetyAlerts free email alert service please click here.

 
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.