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Preview: Drugs.com - FDA MedWatch Alerts

Drugs.com - FDA MedWatch Alerts



FDA MedWatch Alerts from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.



 



Levofloxacin in 5 Percent Dextrose 250mg/50mL by AuroMedics: Recall - Presence of Visible Particulate Matter

Thu, 18 Jan 2018 19:00:00 GMT

Audience: Pharmacy, Risk Manager, Infectious Disease [Posted 01/18/2018] ISSUE: AuroMedics Pharma LLC is voluntarily recalling one lot of Levofloxacin in 5% Dextrose Injection 250mg/50mL in a Single-Use flexible container NDC 55150-243-46, Lot...



Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter - Anaphylaxis and Other Serious Hypersensitivity Reactions

Tue, 16 Jan 2018 15:40:00 GMT

Audience: Pharmacy, Oncology, Nursing ISSUE: Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the postmarketing setting, some requiring hospitalization. These reactions have occurred during or soon...



Prescription Opioid Cough and Cold Medicines: Drug Safety Communication - FDA Requires Labeling Changes

Thu, 11 Jan 2018 13:00:00 GMT

Audience: Family Practice, Pediatrics ISSUE: FDA is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of...



Clopidogrel Tablets USP, 75 mg by International Laboratories: Recall - Product Mislabeling

Thu, 11 Jan 2018 00:00:00 GMT

Audience: Pharmacy, Patient ISSUE: International Laboratories, LLC is voluntarily recalling Lot# 117099A of Clopidogrel Tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as...



Ampicillin and Sulbactam for Injection USP 1.5 g/vial by Auromedics: Recall - Presence of Glass Particles in Vial

Thu, 04 Jan 2018 13:10:00 GMT

Audience: Pharmacy, Risk Manager ISSUE: AuroMedics Pharma is voluntarily recalling one lot of Ampicillin and Sulbactam for Injection USP, 1.5 g in a Single-Dose vial (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g Sulbactam as the sodium...



Compounded Sterile Products by PharMEDium Services: Recall - Lack of Sterility Assurance

Tue, 02 Jan 2018 19:30:00 GMT

Audience: Risk Manager, Pharmacy ISSUE: PharMEDium Services is voluntarily recalling certain lots of drug products to the hospital/user level due to a lack of assurance of sterility. Administration of a drug product intended to be sterile that is...



Linezolid Injection by Auromedics Pharma: Voluntary Recall 600mg/300mL flexible bags- Due to Presence White Particle Matter That Has Been Identified as Mold

Tue, 26 Dec 2017 05:00:00 GMT

Audience: Risk Manager, Pharmacy, Nurse ISSUE: AuroMedics Pharma is voluntarily recalling one lot of Linezolid Injection 600mg/300mL flexible bags, NDC 55150 -242 -51 batch CLZ160007 expiration August 2018 to the hospital level. This batch was...



Long-Acting Beta agonists (LABAs) and Inhaled Corticosteroids (ICS): Drug Safety Communication - Boxed Warning About Asthma-Related Death Removed

Wed, 20 Dec 2017 23:00:00 GMT

Audience: Pharmacy, Pulmonology, Internal Medicine, Family Practice ISSUE: FDA's most prominent warning, the Boxed Warning, about asthma-related death has been removed from the drug labels of medicines that contain both an ICS and LABA. A FDA review...



Pantoprazole Sodium for Injection 40 Mg Per Vial: Recall - Presence of Glass Particles

Wed, 20 Dec 2017 12:30:00 GMT

Audience: Pharmacy, Gastroenterology ISSUE: AuroMedics Pharma LLC is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial, to the hospital level. The product was found to contain glass particles in the vial. This problem...



Gadolinium-based Contrast Agents (GBCAs): Drug Safety Communication - Retained in Body; New Class Warnings

Tue, 19 Dec 2017 13:00:00 GMT

Audience: Radiology, Health Care Professional, Patient ISSUE: FDA is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in...



Blue Pearl All Natural Male Enhancement Supplement: Recall - Undeclared Drug Ingredient

Thu, 14 Dec 2017 13:00:00 GMT

Audience: Consumer [Posted 12/14/2017] ISSUE: Marmex Corp is voluntarily recalling all lots of Blue Pearl All Natural Male Enhancement Supplement, 500mg to the consumer level. FDA analysis has found the products to contain sildenafil. The...



Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics: Recall - Lack of Sterility Assurance and Other Quality Issues

Tue, 05 Dec 2017 15:00:00 GMT

Audience: Pharmacy, Consumer [Posted 12/05/2017] ISSUE: Simple Diagnostics is voluntarily recalling three lots of Pharmacist Choice Alcohol Prep Pads (UPC # 898302001050, NDC # 98302-0001-05), which were manufactured by Foshan Flying Medical...



Albumin Human 25 Percent Solution (AlbuRx 25): Product Information Advisory - Fading Print On Label

Fri, 01 Dec 2017 13:30:00 GMT

Audience: Risk Manager, Critical Care Medicine, Emergency Medicine ISSUE: During routine inspection of retained AlbuRx 25% samples CSL Behring noted the potential for fading print with more effect on the expiration dating on the patient tear off...



Bull Capsules, Chao Jimengnan Tablets by Nutra Labs: Recall - Undeclared Drug Ingredients

Fri, 01 Dec 2017 13:10:00 GMT

Audience: Consumer [Posted 12/01/2017] ISSUE: Nutra Labs Inc. is voluntarily recalling lots sold by their firm of the male enhancement supplements Bull 1800 mg Capsules with the production date of 05/08/2016, and Chao Jimengnan 150 mg Tablets...



Biotin (Vitamin B7): Safety Communication - May Interfere with Lab Tests

Tue, 28 Nov 2017 14:00:00 GMT

Audience: Laboratory, Health Professional, Patient ISSUE: The FDA is alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results...



Riomet (Metformin Hydrochloride Oral Solution): Recall - Microbial Contamination

Mon, 27 Nov 2017 15:10:00 GMT

Audience: Pharmacy, Patient ISSUE: Sun Pharmaceutical Industries is recalling two lots of Riomet (Metformin Hydrochloride Oral Solution), which were found to be contaminated with Scopulariopsis brevicaulis. Use of the affected Riomet potentially...



Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory - Linked to Potentially Life-Threatening Health Problems

Tue, 21 Nov 2017 05:00:00 GMT

Audience: Consumer, Health Professional ISSUE: The U.S. Food and Drug Administration is investigating serious adverse events involving Limbrel, a product in capsule form currently being marketed as a medical food to manage the metabolic processes...



Diphenoxylate Hydrochloride and Atropine Sulfate Tablets by Greenstone: Recall - Possible Sub Potent and Super Potent Tablets

Fri, 17 Nov 2017 05:00:00 GMT

Audience: Pharmacy, Risk Manager, Patient ISSUE: Greenstone, a wholly owned subsidiary of Pfizer Inc., is voluntarily recalling multiple lots of diphenoxylate hydrochloride and atropine sulfate tablets, USP to the consumer level. Greenstone...



Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection: Recall - Presence Of Particulate Matter

Wed, 15 Nov 2017 18:20:00 GMT

Audience: Pharmacy, Cardiology, Risk Manager ISSUE: Baxter International announced it is voluntarily recalling one lot of Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection – distributed between 6/23/2017 and 10/2/2017 in the United...



Febuxostat (Brand Name Uloric): Drug Safety Communication - FDA to Evaluate Increased Risk of Heart-related Death

Wed, 15 Nov 2017 16:00:00 GMT

Audience: Rheumatology, Internal Medicine, Patient ISSUE: FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine...