DRUG RECALLS: FEBRUARY 2011
FEBRUARY 2011: AVANDIA (ROSIGLITAZONE) RECALLED DUE TO RISKS OF CARDIOVASCULAR EVENTS. THIS INFORMATION HAS BEEN ADDED TO THE PHYSICIAN LABELING AND PATIENT MEDICATION GUIDE.
FEBRUARY 2011: HYDROCODONE BITARTRATE AND ACETAMINOPHEN 10MG - 500MG TABLETS (NDC: 0603-3888-20 60 COUNT BOTTLES), PHENOBARBITAL 32.4MG TABLETS (NDC: 0603-5166-32 1000 COUNT LABEL) RECALLED DUE TO INCORRECT PACKAGE LABELING. THIS LABELING MISTAKE CAN LEAD TO ADVERSE EFFECTS SUCH AS RESPIRATORY DEPRESSION, CNS DEPRESSION, COMA, AND DEATH.
FEBRUARY 2011: TRIAD STERILE LUBRICATING JELLY RECALLED DUE TO PRODUCT MAY NOT BE STERILE.
FEBRUARY 2011: INJECTABLE TERBUTALINE (A BROCHODILATOR DRUG) LABEL WAS CHANGED "WARNING AGAINST USE FOR TREATMENT OF PRETERM LABOR". THIS DRUG SHOULD NOT BE USED IN OUTPATIENT AND INPATIENT SETTINGS BECAUSE OF THE POTENTIAL FOR SERIOUS HEART PROBLEMS AND DEATH. SHOULD NOT BE USED IN PREGNANT WOMEN AT ALL BECAUSE IT HAS NOT BEEN SHOWN TO BE EFFECTIVE & SAFETY IN PREGNANT WOMEN THAT ARE TRYING TO PREVENT PRETERM LABOR.
FEBRUARY 2011: ONE LOT OF JANTOVEN WARFARIN SODIUM, USP 3MG TABLETS RECALLED DUE TO MISLABELED BOTTLES CONTAINING HIGHER DOSAGE (10MG).
FEBRUARY 2011: ANTIPSYCHOTIC DRUGS HALDOL, FAZACLO, FANAPT, CLOZARIL, RISPERDAL, ZYPREXA, SEROQUEL, ABILIFY, GEODON, INVEGA, LOXITANE, MOBAN, NAVANE, ORAP, SAPHRIS, STELAZINE, THORAZINE, SYMBYAX WOULD NOW CONSIST A CHANGE OF LABELING ON THE PREGNANCY SECTION OF DRUG LABELS THAT WOULD CONTAIN DEPTH INFORMATION STATING ABOUT POTENTIAL RISK FOR ABNORMAL MUSCLE MOVEMENTS AND WITHDRAWAL SYMPTOMS IN NEWBORNS WHOSE MOTHERS WERE TREATED WITH THESE DRUGS DURING THE 3RD TRIMESTER OF PREGNANCY.
FEBRUARY 2011: EXTENZE TABLETS RECALLED DUE TO UNDECLARED DRUG INGREDIENTS SUCH AS TADALAFIL, SILDENAFIL, & SIBUTRAMINE. LOT 0709241 CONTAINS TADALAFIL & SILDENAFIL, THESE DRUGS ARE USED TO TREAT ERECTILE DYSFUNCTION (ED) THAT MAY INTERACT WITH NITRATES SUCH AS NITROGLYCERIN AND MAY LOWER BLOOD PRESSURE TO DANGEROUSLY LEVELS. LOT 0509075 CONTAINS TADALAFIL & SIBUTRAMINE, SIBUTRAMINE IS A CONTROLLED SUBSTANCE THAT WAS WITHDRAWN FROM THE MARKET ON OCTOBER 2010 FOR SAFETY REASONS. SIBUTRAMINE IS KNOWN TO INCREASE BLOOD PRESSURE AND PULSE RATE.
FEBRUARY 2011: SVELTE 30 (ORANGE & GRAY CAPSULES) RECALLED DUE TO UNDECLARED DRUG INGREDIENT CALLED SIBUTRAMINE. SIBUTRAMINE IS KNOWN TO INCREASE BLOOD PRESSURE AND PULSE RATE. SVELTE 30 HAS NOT BEEN APPROVED BY THE FDA BECAUSE SAFETY & EFFECTIVENESS IS UNKNOWN.
