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November 30, 1999

Roche 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 cereus/Methylobacterium sp).

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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