April 4, 2001ESI Lederle Recalls Methyldopa
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.
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
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.