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SafetyAlerts
July 18, 2000

Rubratope Diagnostic Kits and Capsules Recalled

Princeton, 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.

PRODUCT
a) Rubratope(r)-57 Diagnostic Kit (Cyanocobalamin Co 57), Rx, 4 capsules (NDC #0270-3868-10);

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

CODE
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.

MANUFACTURER
Bristol-Myers Squibb Company, New Brunswick, New Jersey.

RECALLED BY
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.

DISTRIBUTION
Nationwide.

QUANTITY
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, 2000.

 
Selected Recent Recalls


Health Professional:

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

How many did you hear about?

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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.