March 05, 2003
Andrx Pharmaceuticals Has Recalled
The Food and Drug
Administration (FDA) released the following information.
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.
548B002A, 548B002B, 548B003A ,548B003B, 548B004, 548B005A , 548B005B,
548B006 thru 548B010, 548C001,548C002A ,548C002B, 548C003, 548C004A and
548C004B,548C005 through 548C011A, 548C012C,548C012D, 548C013B and
Andrx Pharmaceuticals, Inc., Fort Lauderdale, FL, by letter on November
27, 2002. Firm initiated recall ongoing.
Dissolution Failure: four hour time point (12 month stability station).
VOLUME OF PRODUCT IN COMMERCE
132,181 100's and 6,080 1000's.