July 18, 2000Rubratope Diagnostic Kits and
NJ (SafetyAlerts) - The Food and
Drug Administration (FDA) today reported that Bracco Diagnostics, Inc. is conducting a
recall of certain Rubratope diagnostic kits and capsules because of incorrect capsule
release assay which could lead to a false negative calculation.
a) Rubratope(r)-57 Diagnostic Kit (Cyanocobalamin Co 57), Rx, 4 capsules
b) Rubratope(r) Cyanocobalamin Co 57 Capsules, UPS, Rx, 5 and 10
capsules, intended for the diagnosis of pernicious anemia and as a diagnostic adjunct in
other defects of intestinal vitamin B12 absorption. NDC #0270-3866-10 and 0270-3866-20.
Recall #D-424/425-0. Class III
Lot Numbers and EXP dates: UW408681 10/1/99, UW308661 10/1/99, UW308662 10/1/99, UX408681
10/20/99, UX308661 10/20/99, UX308662 10/20/99, UZ408681 1/6/00, UZ408661 1/6/00, UZ408662
1/6/00, WA408681 1/22/00, WA408661 1/22/00, WA418661 1/22/00, WA408662 1/22/00, WD408681
6/5/00, WD418681 6/5/00, WD408661 6/5/00, WD408662 6/5/00, WD508662 6/5/00, WE108681
5/12/00, WE408661 5/12/00, WE308662 5/12/00, WE408662 5/12/00, WG408681 6/19/00, WG408661
6/19/00, WG408662 6/19/00.
Bristol-Myers Squibb Company, New Brunswick, New Jersey.
Bracco Diagnostics, Inc., Princeton, New Jersey (responsible firm), by field alert letter
on May 5, 2000. Firm-initiated recall ongoing. This is the first public notice
issued by the FDA.
10 kits, 10 bottles of 5 capsules, and 20 bottles of 10 capsules were distributed.
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.
Notice of this product warning was sent via email
to SafeMail subscribers July 18,
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