April 12, 2001Thames Pharmacal Co. Inc.
Recalls Fluocinolone Acetonide Solution
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.
(Rx)Fluocinolone Acetonide Solution, USP, 0.01%, 20 and 60 mL units.
LOT NO. N133, Exp. Date 12/01.
Thames Pharmacal Co., Inc., Ronkonkoma, NY.
Manufacturer, by letter on 3/22/01. Firm-initiated recall ongoing.
KY, FL, GA, NY, IL, MI, LA, AL, MO, WI, CA, TX, PA, MN, OH, and Puerto Rico.
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.