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Monthly Archives: June 2012
Cataplex ACP Cataplex C Pancreatrophin PMG Dietary Supplements Recall
Translation Cataplex ACP, Cataplex C, and Pancreatrophin PMG Dietary Supplements: Recall – Potential for Contamination With Salmonella AUDIENCE: Consumer, Healthcare Professional ISSUE: Standard Process and FDA notified consumers and healthcare professionals of a recall of three dietary supplements due … Continue reading
Posted in Consumer Products, FDA 2012, FDA Recall, Healthcare Professionals
Tagged and Pancreatrophin PMG Dietary Supplements Recall, Cataplex ACP, Cataplex C, Consumer, Contamination With Salmonella, drug risks, FDA notice, FDA warning, Healthcare Professional, Pancreatrophin PMG, Recall
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Ondansetron Zofran IV Drug Safety Communication QT prolongation
TranslationOndansetron (Zofran) IV: Drug Safety Communication – QT prolongation AUDIENCE: Oncology, Surgery, Gastroenterology ISSUE: The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and the public that preliminary results from a recently completed clinical study suggest that a … Continue reading
Posted in FDA 2012, FDA Safety Communication, Gastroenterology, Oncology, Surgery
Tagged drug risks, Drug Safety Communication, FDA Drug Safety Communication, FDA notice, Gastroenterology, Oncology, Ondansetron Zofran IV, Ondansetron Zofran IV Drug Safety Communication QT prolongation, QT prolongation, Surgery
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Vecuronium Bromide For Injection Preservative Free Bedford Laboratories Recall
TranslationVecuronium Bromide For Injection Preservative Free (Bedford Laboratories): Recall – Particulate Matter AUDIENCE: Risk Manager, Pharmacy, Surgery, Anesthesia ISSUE: Bedford Laboratories issued recall of Vecuronium Bromide For Injection, 20 mg vial – NDC #55390‐039‐10, Lot 2067134, Exp. Date 5/31/2013 – … Continue reading
Posted in Anesthesiology, FDA 2012, FDA Recall, Pharmacy, Risk Manager, Surgery
Tagged Anesthesia, Bedford Laboratories, drug recalls, drug risks, FDA recall, Pharmacy, Recall, Risk Manager, Surgery, Vecuronium Bromide For Injection Preservative Free
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ev3 Onyx Liquid Embolic System
Translationev3 Onyx Liquid Embolic System: Safety Communication – Risk of Catheter Entrapment AUDIENCE: Neurology, Surgery ISSUE: FDA notified physicians and patients about the risk of catheter entrapment associated with the use of Onyx. Catheter entrapment happens when the catheter becomes … Continue reading
Posted in FDA 2012, FDA Safety Communication, Neurology, Surgery
Tagged drug risks, Drug Safety Communication, ev3 Onyx Liquid Embolic System, FDA notice, Nursing, Risk of Catheter Entrapment, Safety Communication, Surgery
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Sigma Spectrum Infusion Pump Model 35700 Class 1 Recall
Translation Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion [UPDATED 6/15/12] Expanded Class I Recall-Serial numbers range from 700000 through 794213. All pumps serviced by SIGMA after September 21, 2010, or remediated as part of the initial … Continue reading
Posted in FDA 2012, FDA Recall, Nursing, Risk Manager
Tagged Class 1 Recall, Model 35700, Nursing, Risk Manager, Sigma, Sigma Spectrum Infusion Pump Model 35700 Class 1 Recall, Spectrum Infusion Pump
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Cefepime Label Change drug risks
TranslationCefepime:Label Change- Risk of Seizure in Patients Not Receiving Dosage Adjustments for Kidney Impairment Audience: Health Professional,Infectious Disease, Nephrology Issue: There have been cases of a specific type of seizure called nonconvulsive status epilepticus associated with the use of … Continue reading
Posted in FDA 2012, FDA Warning, Healthcare Professionals, Infectious Disease, Nephrology
Tagged Adverse Effects, Cefepime, Cefepime Label Change, drug effects, drug reactions, drug risks, FDA warning, Health Professional, Infectious Disease, Nephrology, Risk of Seizure, safety label changes
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Nidek Medical Products Class 1 Recall
TranslationNidek Medical Products Mark 5 Nuvo, Nuvo 8, and Nuvo Lite Oxygen Concentrators: Class I Recall – Risk of Fire, Loss of Supplemental Oxygen AUDIENCE: Consumer ISSUE: Capacitor failure may result in a fire hazard and loss of supplemental oxygen. … Continue reading
Posted in Consumer Products, FDA 2012, FDA Recall
Tagged Class 1 Recall, Class I Recall, FDA recall, Loss of Supplemental Oxygen, Mark 5 Nuvo, Nidek Medical Products, Nidek Medical Products Class 1 Recall, Nidek Medical Products Mark 5 Nuvo, Nuvo 8, Nuvo Lite Oxygen Concentrators, Recall, Risk of Fire
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May 2012 Safety Labeling Changes
TranslationThe MedWatch May 2012 Safety Labeling Changes posting includes 41 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The “Summary Page” provides a listing of drug names and … Continue reading
Posted in FDA 2012, FDA Label Change
Tagged 0.5% chlorhexidine gluconate solution and 70% isopropyl alcohol w/w, 2% Chlorhexidine Gluconate, 4% w/v chlorhexidine gluconate, Aciphex, Actoplus Met, Aredia, Avagard Surgical and Healthcare Personnel Hand Antiseptic, benazepril, Biaxin Filmtabs, Biaxin Granules, Biaxin XL Filmtabs, brand of iopromide, Catapres, Catapres-TTS, CHG, Chlorascrub Swabsticks, chlorhexidine gluconate 1% solution and ethyl alcohol 61% w/w, chlorhexidine gluconate 2% and 4%, clarithromycin extended release tablets, clarithromycin for oral suspension, clarithromycin tablets, clonidine, clonidine hydrochloride, Delayed-Release Tablets, Dexilant, dexlansoprazole, dexmethylphenidate hydrochloride, Divigel, Drug Safety Communication, estradiol gel, ethosuximide, FDA notice, Fingolimod, Focalin, Focalin XR, Folotyn, For Delayed-Release Oral Suspension, Gilenya, Hibiclens, Hibistat, Injection Pharmacy Bulk Pack, lansoprazole, Lotensin, May 2012 Safety Labeling Changes, Omeprazole/Sodium Bicarbonate/Magnesium Hydroxide Tablets, pamidronate disodium, pantoprazole sodium, pantoprazole sodium For Injection, pioglitazone hydrochloride plus metformin hydrochloride, pralatrexate injection, Prevacid, PRotonix, rabeprazole sodium, safety label changes, Scrub-Stat 2% and Scrub-Stat 4%, Transdermal Therapeutic System, Ultravist, USP), Zarontin
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Digestive 3 in 1 Health Recall
TranslationDigestive 3 in 1 Health Liquid Dietary Supplement: Recall – Potential for Contamination With Salmonella AUDIENCE: Consumer ISSUE: Botanical Laboratories Inc. and FDA notified consumers and healthcare professionals of a recall of Wellesse Digestive 3 in 1 Health liquid dietary … Continue reading
Introvale levonorgestrel and ethinyl estradiol Tablets Recall
TranslationIntrovale (levonorgestrel and ethinyl estradiol) Tablets: Recall – Packaging Flaw AUDIENCE: Consumer, Pharmacy ISSUE: Sandoz notified the public that it issued a voluntary recall of 10 lots of its generic oral contraceptive Introvale in the US, following a recent report … Continue reading
Posted in Consumer Products, FDA 2012, FDA Recall, Pharmacy
Tagged Birth Control Pills, Consumer, Consumer Products, drug risks, ethinyl estradiol, extended-cycle oral contraceptive, Family Practice, FDA recall, Introvale, Introvale levonorgestrel and ethinyl estradiol Tablets Recall, levonorgestrel, Pharmacy, Recall, Sandoz, tablets
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