1.
Digitek (digoxin tablets, USP) 125 mcg (0.125 mg), an Rx oral cardiotonic -
a
yellow, scored tablet imprinted with a "B" over "145"; single tablet unit dose
blister packs. Packaged as: UD100 tablets (10X10), NDC 51079-945-20; UD 300 tablets (10X30), NDC 51079-945-57; PC300 tablets (10X30), NDC 51079-945-56; and CP180 Patient Compliance Package (6X30), NDC 51079-945-66; Recall # D-291-2008.
2.
Digitek (digoxin tablets, USP) 250 mcg (0.25 mg), an Rx oral cardiotonic -
a
white, scored tablet imprinted with a "B" over "146"; single tablet unit dose blister packs. Packaged as: UD100 tablets (10x10), NDC 51079-946-20 and CP180 Patient Compliance Package, 180 tablets (6X30), NDC 51079-946-66; Recall # D-292-2008.
CODE & LOT NUMBERS:
1. Lot numbers (digoxin tablets, USP) 125 mcg (0.125 mg): 7A666, exp. 7/08; 7F048, exp. 10/08; 7D352, exp. 12/08; 7P862, exp. 3/09; and 8C515, exp. 9/09; Lot number: 6S406, exp. 5/08; Lot numbers: 7J541, exp. 1/09; 7M709, exp. 3/09; 7P965, exp. 4/09; 8A266, exp. 7/09; and 8C514, exp. 9/09; Lot numbers: 7P964, exp. 4/09 and 8B371, exp. 8/09;
2. Lot numbers (digoxin tablets, USP) 250 mcg (0.25 mg): 6S379, exp. 5/08; 7C971, exp. 9/08; 7J525, exp. 1/09; 7V200, exp. 6/09; Lot numbers: 7P963, exp. 4/09 and 8A332, exp. 7/09
RECALLING MANUFACTURER:
UDL Laboratories, Inc., Rockford, IL, by letter on April 28, 2008. Firm initiated recall is ongoing.
REASON:
Super-Potency; UDL repackaged lots of Digitek digoxin tablets that have been recalled by the manufacturer (Actavis) due to the tablets having a thickness approximately double that of their specification.
VOLUME OF PRODUCT IN COMMERCE:
Approximately 65,242 cartons of 100;
Approximately 4,624 cartons of 300; and
Approximately 86,489 cartons of 180.
DISTRIBUTION:
Nationwide
