DRUG RECALLS: MAY 2011

 

MAY 2011: REGENERECT RECALLED DUE TO UNDECLARED DRUG INGREDIENT CALLED SULFOAILEDENAFIL, AN ANALOGUE OF ACTIVE INGREDIENT OF AN FDA APPROVED DRUG USED TO TREAT ERECTILE DYSFUNCTION (ED) MAKING REGENERECT AN UNAPPROVED DRUG. THE PRODUCT POSES A THREAT TO CONSUMERS BECAUSE IT MAY INTERACT WITH  NITRATES FOUND IN SOME PRESCRIPTION DRUGS SUCH AS NITROGLYCERIN AND MAY LOWER BLOOD PRESSURE TO DANGEROUS LEVELS.

MAY 2011: ONE LOT OF 1000 COUNT BOTTLES OF COUMADIN (WARFARIN SODIUM) CRYSTALLINE 5MG TABLETS RECALLED DUE TO TABLETS MAY HAVE HIGHER THAN EXPECTED POTENCY. A DECREASE OF ACTIVE INGREDIENT MAY INCREASE THE RISK OF  CLOTS WHICH IT CAN LEAD TO A HEART ATTACT, STROKE, AND IF THERE IS TOO MUCH ACTIVE INGREDIENT (WHICH IN THIS CASE) THERE IS AN INCREASED RISK OF BLEEDING.

MAY 2011: MULTI-MEX DISTRIBUTOR RECALLED DIETARY SUPPLEMENTS THAT MAY BE LABELED AS ANTIBIOTIC DRUGS.

MAY 2011: AVANDIA (ROSIGLITAZONE) RECALLED DUE TO NEW RESTRICTION FOR PRESCRIBING THESE DIABETES TYPE II DRUGS. HEALTHCARE PROVIDERS AND PATIENTS MUST ENROLL IN A SPECIAL PROGRAM IN ORDER TO PRESCRIBE AND RECEIVE THESE DRUGS.

MAY 2011: FDA NOTIFIED PARENTS, CAREGIVERS, AND HEALTHCARE PROVIDERS NOT TO FEED SIMPLYTHICK (A THICKENING AGENT FOR MANAGEMENT OF SWALLOWING DISORDERS, TO INFANTS BORN BEFORE 37 WEEKS). THE PRODUCT MAY CAUSE NECROTIZING ENTEROCOLITIS (NEC), A LIFE THREATNING CONDITION CHARACTERIZED BY INFLAMMATION AND DEATH OF INTESTINAL TISSUE.

MAY 2011: FENTREXYL FORTE NATURAL RECALLED DUE TO MISLEADING PACKAGING CAUSING IT TO BE CONFUSED WITH AN ANTIBIOTIC. FENTREXYL FORTE NATURAL IS DIETARY SUPPLEMENT ONLY AND DOES NOT CONTAIN ANTIBIOTICS. USE OF THIS PRODUCT BY ILL INDIVIDUALS COULD DELAY TREATMENT FOR SERIOUS ILLNESSES.

MAY 2011: BIRTH CONTROL PILLS CONTAINING DROSPIRANONE (a type of female sex hormone called progestin) MAY POSSIBLY INCREASE RISK OF BLOOD CLOTS. THE RISK IS REPORTED TO BE GREATER THAN 2 OR 3 TIMES GREATER THAN THE RISK OF VENOUS THROMBOEMBOLISM (VTE) ASSOCIATED WITH USING LEVONORGESTREL-CONTAINING PILLS (a different progestin).