Safety
Alert
March 2003
Boehringer Ingelheim Roxane
Laboratories Recalls Micardis Tablets
(anti-hypertensive)
The Food and Drug Administration (FDA) released the following
information.
PRODUCT
Micardis Tablets, (telmisartan) 20 mg, 28 tablets, 4 blister cards of 7
tablets each, Rx only, NDC #00597-0039-28. Recall # D-148-3.
CODE
Lot #106909A, Exp 11/2003; and Lot #205752A, Exp 08/2004.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boehringer Ingelheim Roxane Laboratories, Columbus, OH,
by letter on December 9, 2002.
Manufactured: Boehringer Ingelheim Pharma KG, Ingelheim Germany. Firm
initiated recall ongoing.
REASON
Container defect: loss of integrity of the air tight seal on the blister
cards.
VOLUME OF PRODUCT IN COMMERCE
264 boxes (73 - lot 106909A; and 191- lot 205752A).
DISTRIBUTION
Nationwide.
|