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SafetyAlerts
March 05, 2003

Andrx Pharmaceuticals Has Recalled Diltia XT

 (SafetyAlerts) - The Food and Drug Administration (FDA) released the following information.

PRODUCT
Diltia XT, Extended Release Capsules,(Diltiazem HCl Extended Release
Capsules, USP), 120 mg, 100 and 1000 capsule bottles, Rx only. NDC 62037-
548-01(100's) and NDC 62037-548-10 (1000's). Recall # D-146-3.

CODE
548B002A, 548B002B, 548B003A ,548B003B, 548B004, 548B005A , 548B005B,
548B006 thru 548B010, 548C001,548C002A ,548C002B, 548C003, 548C004A and
548C004B,548C005 through 548C011A, 548C012C,548C012D, 548C013B and
548C014A.

RECALLING FIRM/MANUFACTURER
Andrx Pharmaceuticals, Inc., Fort Lauderdale, FL, by letter on November
27, 2002. Firm initiated recall ongoing.

REASON
Dissolution Failure: four hour time point (12 month stability station).

VOLUME OF PRODUCT IN COMMERCE
132,181 100's and 6,080 1000's.

DISTRIBUTION
Nationwide.

 

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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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.