DRUG RECALLS: AUGUST 2010
AUGUST 2010: 2 LOTS OF NEOPROFEN (IBUPROFEN LYSINE) INJECTION, AN NON-STERODIAL ANTI-INFLAMMATORY THERAPY INDICATED TO CLOSE A CLINICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN PREMATURE INFANTS WEIGHING BETWEEN 500 TO 1500G, WHO ARE NO MORE THAN 32 WEEKS GESTATIONAL AGE WHEN USUAL MEDICAL MANAGEMENT (FLUID RESTRICTION, DIURETICS, RESPIRATORY SUPPORT,ETC) IS INEFFECTIVE. RECALLED DUE TO PRODUCT FAILED TO MEET A VISIBLE PARTICULATE QUALITY REQUIREMENT. LOTS 1734991 & 1922319
AUGUST 2010: A REMINDER THAT NIMODIPINE ORAL CAPSULES AN MEDICATION GIVEN IN CRTICAL CARE SETTING TO TREAT NEUROLOGIC COMPLICATIONS FROM SUBARACHNOID HEMORRHAGE (RUPTURED BLOOD VESSELS IN THE BRAIN) <ONLY AVAILABLE IN CAPSULES> SHOULD BE GIVEN ONLY BY MOUTH OR THROUGH A FEEDING OR NASOGASTRIC TUBE & SHOULD NEVER BE GIVEN BY INTRAVENOUS ADMINISTRATION. INTRAVENOUS INJECTION CAN RESULT IN DEATH, CARDIAC ARREST, SEVERE FALLS IN BLOOD PRESSURE, OTHER HEART RELATED COMPLICATIONS
AUGUST 2010: REVIVEXXX EXTRA STRENGTH RECALLED DUE TO UNDECLARED TADALAFIL. TADALAFIL IS AN FDA APPROVED DRUG FOR MALE ERECTILE DYSFUNCTION MAKING REVIVEXXX EXTRA STRENGTH AN UNAPPROVED DRUG. THIS POSES TO A THREAT TO CONSUMERS BECAUSE TADALAFIL MAY INTERACT WITH NITRATES FOUND IN SOME PRESCRIPTION DRUGS LIKE NITROGLYCERIN AND MAY LOWER BLOOD PRESSURE TO DANGEROUS LEVELS
AUGUST 2010: SOLO SLIM, SOLO SLIM EXTRA STRENGTH RECALLED DUE TO UNDECLARED DRUG INGREDIENT DIDESMETHYL SIBUTRAMINE. SIBUTRAMINE IS A FDA APPROVED DRUG FOR APPETITE SUPPRESSANT FOR WEIGHT LOSS. THIS POSES A THREAT TO CONSUMERS BECAUSE SIBUTRAMINE IS KNOWN TO INCREASE BLOOD PRESSURE OR PULSE RATE IN SOME PATIENTS & MAY PRESENT A RISK IN PATIENTS WITH A HISTORY OF CORONARY ARTERY DISEASE, CONGESTIVE HEART FAILURE, STROKE, & ARRHYTHMIAS
AUGUST 2010: LAMICTAL (LAMOTRIGINE) DRUG USED TO TREAT SEIZURES IN CHILDREN 2YRS AND OLDER & BIPOLAR DISORDER IN ADULTS RECALLED DUE TO RISK OF ASEPTIC MENINGITIS. SYMTOMS OF MENINGITIS MAY INCLUDE HEADACHE, FEVER, STIFF NECK, NAUSEA, VOMITING, RASH, & SENSITIVITY TO LIGHT
AUGUST 2010: MIDODRINE HYDROCHLORIDE USED TO TREAT LOW BLOOD PRESSURE WITHDRAWAL DUE TO THE REQUIRED POST-APPROVAL STUDIES THAT VERIFY THE CLINICAL BENEFIT OF THE DRUG HAVE NOT BEEN DONE
AUGUST 2010: STALEVO (CARBIDOPA/LEVODOPA AND ENTACAPONE) RECALLED DUE TO POSSIBLE INCREASED CARDIOVASCULAR RISK
AUGUST 2010: OCTAGAM (IMMUNE GLOBULIN INTRAVENOUS <HUMAN> ) 5% LIQUID PREPARATION TREATMENT FOR PRIMARY HUMORAL IMMUNODEFICIENCY (PI) SUCH AS CONGENITAL AGAMMAGLOBULINEMIA, WISKOTT-ALDRICH SYNDROME, ETC. RECALLED DUE TO THROMBOEMBOLIC EVENTS WHICH SOME WERE SERIOUS
AUGUST 2010: MASXTREME CAPSULES (NATURAL WELLNESS) USED AS A DIETRY SUPPLEMENT RECALLED DUE TO UNDECLARED DRUG INGREDIENT AMINOTADALAFIL A FDA DRUG APPROVE DRUG TO TREAT ERECTILE DYSFUNCTION (ED) MAKING MASXTREME AN UNAPPROVED NEW DRUG
AUGUST 2010: TIMEOUT CAPSULES USE AS A DIETRY SUPPLEMENT FOR SEXUAL ENHANCEMENT RECALLED DUE TO UNDECLARED DRUG INGREDIENT HYDROXYTHIOHOMOSILDENAFIL A CHEMICAL SIMILAR TO SILDENAFIL (ACTIVE INGREDIENT IN VIAGRA) THIS UNDECLARED DRUG INGREDIENT (CHEMICAL) MAY INTERACT WITH OTHER PRESCRIPTION DRUGS SUCH AS NITRATES INCLUDING NITROGLYCERIN AND CAUSE DANGEROUSLY LOW BLOOD PRESSURE, WHEN BLOOD PRESSURE DROPS SUDDENLY THE BRAIN IS DEPRIVED OF AN ADEQUATE BLOOD SUPPLY WHICH CAN LEAD TO DIZZINESS OR LIGHTHEADEDNESS
