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PRODUCT
Mysoline (primidone) Tablets, 50 mg tablets, 500 count
bottles. Rx Only. Recall # D-112-4.

CODE
Lot Number: J0300071.

RECALLING FIRM/MANUFACTURER
Xcel Pharmaceuticals, Inc., San Diego, CA, by letter on February 6, 2004. Firm initiated recall is ongoing.

REASON
Tablet hardness failure.

VOLUME OF PRODUCT IN COMMERCE
3,728 bottles.

DISTRIBUTION
Nationwide.