The FDA has released the following information.
PRODUCT
Diltia XT Capsules (diltiazem HCI extended-release
capsules, USP) Once-A-Day Dosage, 240 mg, 100 count
bottles, Rx Only. Recall # D-124-4.
CODE
Lot Number/Expiration Date: 550C039 (11/04).
RECALLING FIRM/MANUFACTURER
Andrx Pharmaceuticals, Inc., Fort Lauderdale, FL, by letter on December 19, 2003. Firm initiated recall is ongoing.
REASON
Mislabeling: The recalled product lot was labeled with the incorrect expiration date of November 2004 rather than actual expiration of November 2003.
VOLUME OF PRODUCT IN COMMERCE
6,552.
DISTRIBUTION
Nationwide.
PRODUCT
Diltia XT Capsules (diltiazem HCI extended-release
capsules, USP) Once-A-Day Dosage, 240 mg, 100 count
bottles, Rx Only. Recall # D-124-4.
CODE
Lot Number/Expiration Date: 550C039 (11/04).
RECALLING FIRM/MANUFACTURER
Andrx Pharmaceuticals, Inc., Fort Lauderdale, FL, by letter on December 19, 2003. Firm initiated recall is ongoing.
REASON
Mislabeling: The recalled product lot was labeled with the incorrect expiration date of November 2004 rather than actual expiration of November 2003.
VOLUME OF PRODUCT IN COMMERCE
6,552.
DISTRIBUTION
Nationwide.
