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April 4, 2001

ESI Lederle Recalls Methyldopa Tablets

Philadelphia, PA (SafetyAlerts) - The Food and Drug Administration (FDA) said today that ESI Lederle has recalled certain Methyldopa Tablets because of tablet discoloration.

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

(Rx) Methyldopa Tablets, USP, 250 mg, 100 count bottles.

Recall #D-151-1.

LOT NO. 465-916, Exp. Date 6/02, Batch #1404.

Wyeth-Ayerst/Lederle, Pearl River, New York.

ESI Lederle, Philadelphia, PA., by certified mail on 2/23/01. Firm-initiated recall ongoing.

AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and Puerto Rico.

14,402 bottles of 100.

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.