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March 15, 2000

Contract Pharmacal Recalls Major, Contract Pharmacal and Breckenridge Brand Urinary Antiseptic Film Coated Tablets

Hauppauge, NY (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Contract Pharmacal Corporation (CPC) is recalling Urinary Antiseptic Film Coated Tablets because of tablet discoloration.

Over 72,000 of the recalled Urinary Antiseptic Film Coated Tablets, (Methenamine 40.8 mg) were distributed in 100 and 1,000 tablets bottles in Michigan, New York, Florida, Georgia, Pennsylvania, California, Kentucky, Ohio, Tennessee, Connecticut, West Virginia, Louisiana, Indiana, New Jersey and Puerto Rico.

The NDC number for these products are:
Contract Pharmacal Corporation- NDC #10267-1724-1 & 10267-1724-4
Major Pharmaceuticals - NDC #0904-5369-60
Breckenridge Pharmaceutical - NDC #51991-027-01.

Each bottle bears one of the following Lot Numbers:
081230 EXP 2/00, 081323 EXP 3/00, 081493 EXP 4/00, 083889 EXP 10/00, 084325 EXP 1/01, 084326 EXP 1/01, 084685 EXP 4/01, 091564 EXP 5/01, 091648 EXP 6/01 091896 EXP 7/01 and 092891 EXP 8/01.

This ongoing Class III recall was initiated by Contract Pharmacal by letter on January 11, 2000, followed by visit on January 20-21, 2000.  This is the first public notice issued by the FDA.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #d-245-0

Notice of this product warning was sent via email to SafeMail subscribers March 15, 2000.

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Health Professional:

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During 2000 there were over
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