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SafetyAlerts
August 27, 2003

Hoffmann La Roche Has Recalled Accutane Capsules

(SafetyAlerts) - The Food and Drug Administration (FDA) released the following information.

PRODUCT
a) Accutane Capsules, (Isotrentinoin) 10 mg, prescription
pak of 10 capsules, Rx only, Roche Laboratories, Inc.,
Nutley, NJ. Recall # D-314-3;
b) Accutane Capsules, (Isotretinoin) 20 mg, prescription
pak of 10 capsules, Rx only, Roche Laboratories, Inc.,
Nutley, NJ. Recall # D-315-3;
c) Accutane Capsules, (Isotretinoin) 40 mg, prescription
pak of 10 capsules, Rx only, Roche Laboratories, Inc.,
Nutley, NJ. Recall # D-316-3.

CODE
Any code missing labeling.

RECALLING FIRM/MANUFACTURER
Hoffmann La Roche, Inc., Nutley, NJ, by letters, and telephone on July 28/31, 2003. Firm initiated recall is ongoing.

REASON
Mislabeled; the yellow qualification sticker does not contain the words "No refills allowed".

VOLUME OF PRODUCT IN COMMERCE
Unknown.

DISTRIBUTION
Nationwide
.

 
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Health Professional:

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During 2000 there were over
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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.