Baxter IV Solutions: Recall - Potential Presence of Particulate Matter
Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, stroke, heart attack or damage to other organs such as the kidney or liver. (Source: FDA MedWatch)
Source: FDA MedWatch - January 5, 2016 Category: American Health Source Type: news
Noxafil (posaconazole): Drug Safety Communication - Dosing Errors when Switching between Different Oral Formulations; Label Changes Approved
Direct mg for mg substitution of the two formulations can result in drug levels that are lower/higher than needed to effectively treat certain fungal infections. (Source: FDA MedWatch)
Source: FDA MedWatch - January 4, 2016 Category: American Health Source Type: news
4mg Norepinephrine Bitartrate (16mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 8mg Norepinephrine Bitartrate (32mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag by Pharmedium: Recall - Discoloration
Discoloration is indicative of degradation and could result in decreased potency due to oxidation of norepinephrine bitartrate. (Source: FDA MedWatch)
Source: FDA MedWatch - December 31, 2015 Category: American Health Source Type: news
Etest PIP/TAZO/CON-4 PTC 256 by bioMérieux: Class I Recall – Potential for Test Result Error
Error may result in inappropriate treatment of a patient’s infection and could cause serious health consequences, including increased time in the hospital, unnecessary tests or procedures, treatment failure, sepsis, and even death. (Source: FDA MedWatch)
Source: FDA MedWatch - December 29, 2015 Category: American Health Source Type: news
ED-530XT Duodenoscopes by FUJIFILM Medical Systems, U.S.A.: Safety Communication - FUJIFILM Medical Systems Validates Revised Reprocessing Instructions
The FDA reviewed the revised reprocessing instructions and the validation data and determined they meet the Agency’s expectations. (Source: FDA MedWatch)
Source: FDA MedWatch - December 23, 2015 Category: American Health Source Type: news
Perseus A500 Anesthesia Workstation by Draeger: Class I Recall - Faulty Power Switch May Cause Device to Stop Working
If this occurs, ventilation may fail and the patient may not receive either anesthesia or enough oxygen. (Source: FDA MedWatch)
Source: FDA MedWatch - December 23, 2015 Category: American Health Source Type: news
La' Trim Plus, Jenesis and Oasis by BeeXtreme: Recall - Undeclared Drug Ingredients
Risk of increased blood pressure and/or pulse rate may present significant risk for patients with a history of CAD, CHF, arrhythmias or
stroke. Potentially serious GI disturbances, irregular heartbeat, and cancer with long-term use. (Source: FDA MedWatch)
Source: FDA MedWatch - December 23, 2015 Category: American Health Source Type: news
Various Products Distributed for Weight Loss by Bee Extremely Amazed: Recall - Undeclared Drug Ingredients
Risk of increased blood pressure and/or pulse rate may present significant risk for patients with a history of CAD, CHF, arrhythmias or
stroke. Potentially serious GI disturbances, irregular heartbeat, and cancer with long-term use. (Source: FDA MedWatch)
Source: FDA MedWatch - December 23, 2015 Category: American Health Source Type: news
Apexxx by Nuway Distributors: Recall - Undeclared Drug Ingredient
Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels that may be life threatening. (Source: FDA MedWatch)
Source: FDA MedWatch - December 23, 2015 Category: American Health Source Type: news
Hand-held Laser Pointers: FDA Safety Communication - Risk of Eye and Skin Injuries
Lasers that emit more than 5mW visible light power can cause irreversible eye injury of increasing severity as the power increases. High-powered laser pointers can irritate or even burn the skin. (Source: FDA MedWatch)
Source: FDA MedWatch - December 22, 2015 Category: American Health Source Type: news
Smart Lipo: Recall - Undeclared Drug Ingredients
Risk of increased blood pressure and/or pulse rate, may present significant risk for patients with a history of CAD, CHF, arrhythmias or stroke. Potentially serious GI disturbances, irregular heartbeat, and cancer with long-term use. (Source: FDA MedWatch)
Source: FDA MedWatch - December 18, 2015 Category: American Health Source Type: news
Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication - FDA Eliminates the Risk Evaluation and Mitigation Strategy (REMS)
The REMS is no longer necessary to ensure that the benefits of rosiglitazone medicines outweigh their risks. (Source: FDA MedWatch)
Source: FDA MedWatch - December 16, 2015 Category: American Health Source Type: news
Chariot Guiding Sheath by Boston Scientific: Recall - Risk of Shaft Separation
Device failure could lead to embolism of device fragments, which could lead to obstruction of blood flow or additional intervention to remove a device fragment. (Source: FDA MedWatch)
Source: FDA MedWatch - December 11, 2015 Category: American Health Source Type: news
Baclofen Active Pharmaceutical Ingredient from Taizhou Xinyou Pharmaceutical and Chemical: FDA Statement - FDA Warns of Potential Contamination
The affected lots may potentially pose serious safety risks for U.S. patients who use or receive injectable drug products compounded with
the affected baclofen, especially when administered directly into the spinal column. (Source: FDA MedWatch)
Source: FDA MedWatch - December 10, 2015 Category: American Health Source Type: news
Pink Bikini Dietary Supplement by Lucy's Weight Loss System: Recall - Undeclared Drug Ingredient
Use of product may increase the risk of fatal heart attack or stroke, especially if used long term or taken in high doses, or if there is a history of heart disease. (Source: FDA MedWatch)
Source: FDA MedWatch - December 10, 2015 Category: American Health Source Type: news
