Tag Archives: OBGYN

Natus Medical Incorporated Olympic Cool Cap System Class I Recall

Posted on December 13, 2012 by Ws Revelations

Translation Natus Medical Incorporated, Olympic Cool-Cap System: Class I Recall – Control Screen Freezes During Treatment AUDIENCE: Risk Manager, OB/GYN, Pediatrics ISSUE: FDA notified healthcare professionals of a Class I Recall of the Olympic Cool-Cap System, because the device’s Control … Continue reading →

Posted in FDA 2012, FDA Recall, OBGYN, Pediatrics, Risk Manager | Tagged Class 1 Recall, Class I Recall, FDA recall, Natus Medical Incorporated, Natus Medical Incorporated Olympic Cool Cap System Class I Recall, OBGYN, Olympic Cool Cap System, Pediatrics, Recall, Risk Manager | Comments Off

Generic Ultrasound Transmission Gel Safety Communication

Posted on April 19, 2012 by Ws Revelations

TranslationOther‐Sonic Generic Ultrasound Transmission Gel: Safety Communication – Risk of Bacterial Contamination AUDIENCE: Risk Manager, OB/GYN, Radiology, Infectious Disease ISSUE: FDA notified health care professionals and facilities to STOP using Other‐Sonic Generic Ultrasound Transmission Gel manufactured June though December 2011, … Continue reading →

Posted in FDA 2012, FDA Warning, Infectious Disease, OBGYN, Radiology, Risk Manager | Tagged drug risks, FDA notice, Generic Ultrasound Transmission Gel, Infectious Disease, OBGYN, Other‐Sonic, Radiology, Risk Manager, Safety Communication | Comments Off

Birth Control Pills Health Risks

Posted on April 10, 2012 by Ws Revelations

TranslationBirth Control Pills Containing Drospirenone: Label Change-Products may be associated with a higher risk for blood clots AUDIENCE: OBGYN, Family Practice, Patient ISSUE: FDA has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots … Continue reading →

Posted in Family Practice, FDA 2012, FDA Label Change, OBGYN, Patients | Tagged Birth Control Pills, Birth Control Pills Health Risks, Drospirenone, drug risks, Family Practice, FDA notice, Health Risks, higher risk for blood clots, OBGYN, safety label changes | Comments Off

Norgestimate and Ethinyl Estradiol Tablets Recall

Posted on February 29, 2012 by Ws Revelations

TranslationNorgestimate and Ethinyl Estradiol Tablets: Recall – Packaging Error, Potential for Incorrect Dosing Regimen AUDIENCE: OB/GYN, Pharmacy, Patient ISSUE: Glenmark Generics Inc. issued a nationwide, consumer-level recall of seven (7) lots of Norgestimate and Ethinyl Estradiol Tablets USP (0.18 mg/0.035 … Continue reading →

Posted in OBGYN, Pharmacy | Tagged Birth Control Pills, Dietary Supplements, drug risks, Ethinyl Estradiol Tablets, Family Practice, FDA recall, Norgestimate, Norgestimate and Ethinyl Estradiol Tablets Recall, OBGYN, Oral Contraceptives, Packaging Error, Patient, Pharmacy, Recall | Comments Off

Pfizer Birth Control Pills Lo Ovral 28 Recall

Posted on February 1, 2012 by Ws Revelations

TranslationPfizer Birth Control Lo/Ovral-28 (Norgestrel/EthinylEstradiol) Tablets: Recall – Possibility of Inexact Tablet Counts or Out of Sequence Tablets AUDIENCE: OB/GYN, Healthcare Professionals, Consumers ISSUE: Pfizer Inc. notified healthcare professionals and consumers that it recalled 14 lots of Lo/Ovral-28 (norgestrel and … Continue reading →

Posted in Consumer Products, FDA 2012, FDA Recall, Healthcare Professionals, OBGYN | Tagged Birth Control Pills, Consumers, drug risks, Family Practice, FDA recall, Healthcare Professionals, Lo Ovral 28, OBGYN, Pfizer, Pfizer Birth Control Pills Lo Ovral 28, Pharmacy, Recall | Comments Off

Vagifresh Ball Vagifresh Gel Female One Recall

Posted on January 23, 2012 by Ws Revelations

TranslationVagifresh Ball, Vagifresh Gel, Female One: Recall – Undeclared Drug Ingredient, Bacterial Contamination AUDIENCE: Consumer, OB/GYN ISSUE: USA Far Ocean Group Inc. notified the public of a recall of Vagifresh Ball and Vagifresh Gel, sold as cosmetics. Vagifresh Gel was found … Continue reading →

Posted in Consumer Products, FDA 2012, FDA Recall, FDA Warning, OBGYN | Tagged Bacterial Contamination, drug, drug risks, fda, FDA notice, FDA recall, FDA warning, Female One, OBGYN, Recall, Undeclared Drug Ingredient, USA Far Ocean Group Inc, Vagifresh Ball, Vagifresh Ball Vagifresh Gel Female One Recall, Vagifresh Gel | Comments Off

Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants Drug Safety Communication

Posted on December 28, 2011 by Ws Revelations

TranslationSelective Serotonin Reuptake Inhibitor (SSRI) Antidepressants: Drug Safety Communication – Use During Pregnancy and Potential Risk of Persistent Pulmonary Hypertension of the Newborn Including Celexa (citalopram); Lexapro (escitalopram); Prozac, Sarafem, Symbyax (fluoxetine); Luvox, Luvox CR (fluvoxamine); Paxil, Paxil CR, … Continue reading →

Posted in Family Practice, FDA 2011, FDA Notice, OBGYN, Psychiatry | Tagged (SSRI), Antidepressants, Celexa (citalopram), Dietary Supplements, Drug Safety Communication, Family Practice, FDA notice, Lexapro (escitalopram), Luvox, Luvox CR (fluvoxamine), OBGYN, Paxil, Paxil CR, Pexeva (paroxetine), Prozac, Psychiatry, Sarafem, Selective Serotonin Reuptake Inhibitor, Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants, Symbyax (fluoxetine), Viibryd (vilazodone), Zoloft (sertraline) | Comments Off

Qualitest Pharmaceuticals Oral Contraceptives Recall

Posted on September 17, 2011 by Ws Revelations

TranslationQualitest Pharmaceuticals Oral Contraceptives: Recall – Packaging Error includes Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20, Orsythia, Previfem, Tri-Previfem AUDIENCE: Consumer, Pharmacy, OB/GYN ISSUE: Qualitest Pharmaceuticals issued a nationwide, retail-level recall of multiple lots of … Continue reading →

Posted in Consumer Products, FDA 2011, FDA Recall, OBGYN, Pharmacy | Tagged Cyclafem 1/35, Cyclafem 7/7/7, Emoquette, FDA recall, Gildess FE 1.5/30, Gildess FE 1/20, OBGYN, Oral Contraceptives, Orsythia, Previfem, Qualitest Pharmaceuticals, Tri-Previfem | Comments Off

Diflucan (fluconazole) Birth Defects

Posted on August 4, 2011 by Ws Revelations

TranslationDiflucan (fluconazole): Drug Safety Communication – Long-term, High-dose Use During Pregnancy May Be Associated With Birth Defects AUDIENCE: OBGYN, Pharmacy, Infectious Disease ISSUE: FDA is informing the public that treatment with chronic, high doses (400-800mg/day) of Diflucan (fluconazole) during the … Continue reading →

Posted in FDA 2011, FDA Notice, FDA Warning, OBGYN, Pharmacy | Tagged Birth Defects, Diflucan, FDA notice, FDA warning, Fluconazole, Infectious Disease, OBGYN, Pharmacy | Comments Off

Antipsychotic drugs: Class Labeling Change – Treatment During Pregnancy and Potential Risk to Newborns

Posted on May 15, 2011 by Ws Revelations

TranslationAntipsychotic drugs: Class Labeling Change – Treatment During Pregnancy and Potential Risk to Newborns including Haldol, FazaClo, Fanapt, Clozaril, Risperdal, Zyprexa, Seroquel, Abilify, Geodon, Invega, Loxitane, Moban, Navane, Orap, Saphris, Stelazine, Thorazine, Symbyax AUDIENCE: Psychiatry, OBGYN ISSUE: FDA notified healthcare … Continue reading →

Posted in FDA Warning | Tagged Abilify, Antipsychotic Drugs, Clozaril, Fanapt, FazaClo, FDA notice, FDA warning, Geodn, Haldol, Invega, labeling change, Loxitane, Moban, Navane, newborn risk, OBGYN, Orap, Psychiatry, Risperdal, Saphris, Seroquel, Stelazine, Symbyax, Thorazine, Zyprexa | Comments Off