March 15, 2000Contract 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
The NDC number for these products
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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