November 30, 1999Roche
Laboratories, Inc. Rocaltrol Capsules Recalled
Nutley, NJ (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that Roche Laboratories, Inc. is recalling one lot of
Rocaltrol Capsules because of potential microbial contamination (Bacillus
The recalled product is Rocaltrol
Capsules, (Calcitriol), 0.25 mcg, Rx, in 100 capsule bottles - NDC #004-0143-01.
This Class II recall was initiated by
the company via telephone on April 6, 1999 and on April 8, 1999 by letter. This is
the first notice the FDA has issued to the general public of the recall. The FDA
considers this recall to be complete.
Over 173 bottles were distributed
nationwide and bear the lot numbers and expiration date of 0419 EXP 10/31/00
Questions concerning this recall may
be directed to the FDA at 1-888-INFO-FDA.
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