June 6, 2000Daily Vitamins Recalled for
NY (SafetyAlerts) - The Food and
Drug Administration (FDA) today reported that Hi-Tech Pharmacal Company, Inc. is recalling
certain Rugby Daily Vitamins and H-T Dalyvite Liquid, in 8 and 16-ounce bottles , because
the products are contaminated with yeast.
Lot number appearing on both labels is 910624 EXP 12/01. Product number specific to the
Rugby label is 602-0412. The Hi-Tech label erroneously lists NDC #50383-624-16, This is
not a drug.
Hi-Tech Pharmacal Company, Inc., Amityville, New York.
Manufacturer, by telephone on March 8, 2000, followed by letter sent on March 9, 2000.
The Hi-Tech labeled product was distributed to the following states: Maine, Indiana, New
York, California, North Carolina, Michigan, Texas, New Jersey, Ohio, Alabama, Missouri,
Connecticut, Florida, Washington State, Oregon, Utah, Puerto Rico. The Rugby labeled
product was distributed to Alabama only.
16,857 bottles were distributed; firm estimated that 60 percent of the product remained on
the market at time of recall initiation.
This ongoing Class III recall
was initiated by the company, by telephone on March 8, 2000, followed by letter sent on
March 9, 2000. This is the first public notice issued by the FDA.
Questions concerning this recall may
be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #f-472-0
Notice of this product warning was
sent via email to SafeMail
subscribers June 6, 2000.
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