DRUG RECALLS: OCTOBER 2010


OCTOBER 2010: SLIMMING BEAUTY BITTER ORANGE SLIMMING CAPSULES RECALLED DUE TO UNDECLARED DRUG INGREDIENT SIBUTRAMINE WHICH IT IS NOT LISTED ON THE PRODUCT LABEL. IT CAN EFFECT THOSE WITH CARDIOVASCULAR CONDITIONS BECAUSE IT CAN LEAD TO ELEVATED BLOOD PRESSURE, STROKE, AND HEART ATTACK. HEALTHY CONSUMERS TAKING THIS DRUG CAN EXPERIENCE ANXIETY, NAUSEA, HEART PALPITATIONS, A RACING HEART, INSOMNIA, & ELEVATED BLOOD PRESSURE.

OCTOBER 2010: MERIDIA (SIBUTRAMINE) AN OBESITY DRUG RECALLED DUE TO INCREASED OF HEART ATTACK AND STROKE.

OCTOBER 2010: LIPITOR (ATORVASTATIN) 40 MG RECALLED SPECIFIC BOTTLES DUE TO SMALL NUMBER OF REPORTS OF AN UNCHARACTERISTIC ODOR RELATED TO THE BOTTLES IN WHICH LIPITOR IS PACKAGED.

OCTOBER 2010: BISPHOSPHONATES (OSTEOPOROSIS DRUGS) IS DUE FOR A LABEL CHANGE FOR RISK OF ATYPICAL FRACTURES OF THE THIGH KNOWN AS SUBTROCHANTERIC AND DIAPHYSEAL FEMUR FRACTURES FOR PATIENTS TAKING BISPHOSPHONATES MEDICATIONS. THIS LABEL CHANGE INFORMATION WILL BE ADDED IN THE "WARNING & PRECAUTIONS" SECTION.

OCTOBER 2010: TYLENOL 8 HOUR CAPLETS- 50 COUNT BOTTLES RECALLED DUE TO SMALL NUMBER OF COMPLAINTS OF A MUSTY OR MOLDY ODOR THAT IS THOUGHT TO BE CAUSED BY THE PRESENCE OF TRACE AMOUNTS OF A CHEMICAL CALLED 2,4,6-TRIBROMOANISOLE.

OCTOBER 2010: GnRH AGONISTS (GONADOTROPIN-RELEASING HORMONE) WILL HAVE A NEW DRUG LABEL ADDED IN THE WARNINGS AND PRECAUTION SECTION STATING THERE IS AN INCREASED RISK OF DIABETES & CERTAIN CARDIOVASCULAR DISEASE SUCH AS HEART ATTACK, STROKE, & SUDDEN CARDIAC ARREST IN MEN RECEIVING THESE DRUGS FOR THE TREATMENT OF PROSTATE CANCER.

OCTOBER 2010: INVIRASE (SAQUINAVIR) AN ANTIVIRAL MEDICATION HAS A NEW RISK LABEL ADDED TO THE WARNINGS & PRECAUTIONS STATING NEW RISK OF ABNORMAL HEART PHYTHM WHEN USED TOGETHER WITH ANOTHER ANTIVIRAL MEDICATION SUCH AS NORVIR (RITONAVIR).

OCTOBER 2010: FENTANYL TRANSDERMAL SYSTEM RECALLED DUE TO ACTIVE INGREDIENT RELEASING FASTER THAN SPECIFIED. THIS CAN LEAD TO ADVERSE EFFECTS SUCH AS EXCESSIVE SEDATION, RESPIRATORY DEPRESSION, HYPOVENTILATION (SLOW BREATHING), & APNEA (TEMP SUSPENSION OF BREATHING).

OCTOBER 2010: HYLAND'S TEETHING TABLETS RECALLED DUE TO RISK OF HARM TO CHILDREN. THIS PRODUCT CONTAINS BELLADONNA A SUBSTANCE THAT CAN CAUSE SERIOUS HARM IF GIVEN IN LARGE DOSES. IT IS IMPORTANT THAT BELLADONNA IS CAREFULLY CONTROLLED.

OCTOBER 2010: METHOTREXATE INJECTION, 50MG/2ML & 250MG/10ML VIALS RECALLED DUE TO SMALL GLASS FLAKES DETECTED IN A LIMITED NUMBER OF FOUR VIALS IN FOUR LOTS. THE FLAKES ARE RESULT FROM DELAMINATION OF THE GLASS USED TO MANUFACTURE THE VIALS OF THE TWO DOSAGE PRESENTATIONS. THIS PRODUCT GIVEN INTRAVENOUSLY CAN LEAD TO SERIOUS ADVERSE EFFECTS SUCH AS LOCAL DAMAGE TO BLOOD VESSELS IN THE LUNGS, LOCALIZED SWELLING, & GRANULOMA FORMATION. THIS PRODUCT GIVEN INTRAMUSCULAR COULD RESULT IN FOREIGN-BODY INFLAMMATORY RESPONSE, WITH LOCAL PAIN, SWELLING AND POSSIBLY LONG TERN GRANULOMA FORMATION.

OCTOBER 2010: HEPARIN SODIUM RECALLED DUE TO TESTING INDICATING TRACE AMOUNT OF OVERSULFATED CHONDROITIN SULFATE (OSCS) CONTAMINANT