Recall Of Prescription Cough and Cold Drugs by Neilgen Pharma and Advent Pharmaceutical

CONTACT: BHARAT PATEL, PRESIDENT (609) 448-5500

NEILGEN PHARMA INC. OF WESTMINSTER, MD AND ADVENT PHARMACEUTICAL OF EAST WINDSOR, NJ ARE RECALLING ALL PRESCRIPTION COUGH AND COLD DRUG PRODUCTS SOLD ON OR AFTER MARCH 5, 2008. NEILGEN PHARMA AND ADVENT PHARMACEUTICAL ARE CONTRACT MANUFACTURERS FOR THESE PRODUCTS AND ARE RECALLING THE LISTED PRODUCTS BELOW DUE TO THE UNAPPROVED DRUG PRODUCT CATEGORY.

CONSUMERS TAKING THESE RECALL PRODUCTS WHICH IS BEING RECALLED SHOULDSTOP USING AND RETURN PRODUCT TO PLACE OF PURCHASE AND CONTACT THEIR PHYSICIAN OR HEALTHCARE PROVIDER TO OBTAIN A REPLACEMENT MEDICATION OR PRESCRIPTION.

SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED BY FDA. HOWEVER, PATIENT EXPOSURE TO AFFECTED PRODUCTS IS NOT LIKELY TO CAUSE ADVERSE HEALTH CONSEQUENCES. BOTH NEILGEN PHARMA AND ADVENT PHARMA HAVE STOPPED THE PRODUCTION OF THESE PRODUCTS AND NO INJURIES HAVE BEEN REPORTED TO DATE.

THIS PRECAUTIONARY ACTION IS FOCUSED ON REMOVING PRODUCTS TO THE RETAIL LEVEL ONLY. FDA HAS BEEN APPRISED OF THIS ACTION. ALL OF THE PRODUCTS UNDER RECALL WERE DISTRIBUTED TO WHOLESALERS LOCATED IN ALABAMA AND NORTH CAROLINA.

THE DRUG PRODUCTS CAN BE IDENTIFIED BY PROVIDED NAME, DESCRIPTION AND LOT NUMBERS.

INQUIRIES RELATED TO THIS RECALL SHOULD BE ADDRESSED TO ADVENT PHARMA CUSTOMER SERVICES AT 1-888-634-5522. REPRESENTATIVE IS AVAILABLE MONDAY THROUGH FRIDAY, 8 A.M. TO 5 P.M. EST. ADVERSE REACTIONS OR QUALITY PROBLEMS EXPERIENCED WITH THE USE OF THIS PRODUCT MAY BE REPORTED TO THE FDA’S ADVERSE EVENT REPORTING PROGRAM EITHER ONLINE, BY REGULAR MAIL OR BY FAX.

THIS RECALL INCLUDES ALL LOTS MANUFACTURED/DISTRIBUTED ON OR AFTER MARCH 5, 2008 WITHIN EXPIRATION DATE OF THE PRODUCT LISTED BELOW.

ADVENT PHARMA RECALLED PRODUCTS

NEILGEN PHARMA RECALLED PRODUCTS