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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
May 20, 1998

PRODUCT
Luvox (Fluvoxamine Maleate) 100 mg, in unit dose blisters (hospital use) of 10 tablets with 10 tablets per blister card, Rx, indicated for the treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder(OCD), as defined in the DMS-III-R.

Recall #D-135-8. CODE Lot #88007.

MANUFACTURER
Solvay Pharmaceuticals, Inc., Marietta, Georgia.

RECALLED BY
Manufacturer, by letter sent on April 7, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
4,944 units were distributed.

REASON
Some units are missing the strength declaration.

 

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.