June 21, 2001Zenith Laboratories Caribe Inc.
Recalls Indapamide Tablets
PR (SafetyAlerts) - The Food and
Drug Administration (FDA) said today that Zenith Laboratories Caribe Inc. has recalled
certain Indapamide Tablets because of illegible monograph on tablets.
This is the first public notice of
this Class III
recall issued by FDA.
Indapamide Tablets, USP 2.5 mg, NDC 0172-4259-60 (100 count) and NDC 0172-4259-80
(1000 count)package in bottles of 100 and 1000 tablets. ANDA 74-299. Rx product.
Lot no. 4259-710. Exp. Date 10/02.
Zenith Laboratories Caribe, Inc., Cidra, PR.
Manufacturer, by letter on 5/30/00.
12,334 bottles (100 count) and 1,602 (1000 count).
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 June 21,
2001. For more information regarding the SafetyAlerts free email alert service
please click here.