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SafetyAlerts
June 6, 2002

Roche Laboratories Has Recalled Rocaltrol (calcitriol) Oral Solution

Nutley, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) said Roche Laboratories has recalled Rocaltrol (calcitriol) Oral Solution

PRODUCT
Rocaltrol (calcitriol) Oral Solution, 1 mcg/ml, 15 ml bottles, Rx only.
Recall # D-284-2.

CODE
Lot Number: U0005 exp. 2/2003.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Laboratories Nutley, NJ, by letters on April 19, 2002.
Manufacturer: Hoffmann La Roche, Nutley, NJ. Firm initiated recall is ongoing.

REASON
Subpotent; active ingredient calcitriol (18 month stability).

VOLUME OF PRODUCT IN COMMERCE
5,692 bottles.

DISTRIBUTION
Nationwide
.

 
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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.