Ginseng Kianpi Pil: Public Notification - Undeclared Drug Ingredients
Risk of impaired ability to fight infections, high blood sugar levels, muscle injuries and psychiatric problems. Undeclared drug ingredients may also cause serious side effects when combined with other medications. (Source: FDA MedWatch)
Source: FDA MedWatch - October 31, 2014 Category: American Health Source Type: news
Baby Wipes by Nutek Disposables, Inc.: Recall - May Contain Bacteria
Those with weakened immune system or chronic lung disease may be more susceptible to infections with B. cepacia. (Source: FDA MedWatch)
Source: FDA MedWatch - October 27, 2014 Category: American Health Source Type: news
Intravia Containers by Baxter: Recall - Particulate Matter
Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. Posted 10/25/2014 (Source: FDA MedWatch)
Source: FDA MedWatch - October 25, 2014 Category: American Health Source Type: news
Assured Brand Naproxen Sodium Tablets by Contract Packaging Resources, Inc.: Recall - Packaging Mix-Up
Risk of allergic reactions, from mild irritation or hives to serious reactions such as anaphylaxis that may be life-threatening. (Source: FDA MedWatch)
Source: FDA MedWatch - October 22, 2014 Category: American Health Source Type: news
Saba Shark Cartilage Complex, 60 Capsule Bottles: Recall - Possible Salmonella Contamination
Salmonella can cause serious and sometimes fatal infections in young children frail or elderly people, and others with weakened immune systems. Posted 10/20/2014 (Source: FDA MedWatch)
Source: FDA MedWatch - October 20, 2014 Category: American Health Source Type: news
Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall - Particulate Matter
Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response to the particulate or microembolic effects. (Source: FDA MedWatch)
Source: FDA MedWatch - October 17, 2014 Category: American Health Source Type: news
September 2014
Drug Safety Labeling Changes includes 55 products with revisions to Prescribing Information. (Source: FDA MedWatch)
Source: FDA MedWatch - October 16, 2014 Category: American Health Source Type: news
LifeCare Flexible Intravenous Solutions by Hospira, Inc.: Recall - Potential for Leakage
A puncture in the primary container may be difficult to detect and lead to contamination, compromised sterility, and other adverse events. (Source: FDA MedWatch)
Source: FDA MedWatch - October 15, 2014 Category: American Health Source Type: news
Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes by Covidien: Field Safety Alert - Electrodes Will Not Connect with Philips FR3 or FRx AED units
The mismatch of these devices could contribute to a delay in resuscitation and may contribute to subsequent death. (Source: FDA MedWatch)
Source: FDA MedWatch - October 13, 2014 Category: American Health Source Type: news
Sit and Slim II: Public Notification - Hidden Drug Ingredients
FDA analysis found these products to contain undeclared Sibutramine, which may increase blood pressure and/or pulse rate, and may also interact in life-threatening ways with other medications. (Source: FDA MedWatch)
Source: FDA MedWatch - October 10, 2014 Category: American Health Source Type: news
CareFusion EnVe and ReVel Ventilators: Class 1 Recall - Power Connection Failure
Ventilator shut-off from power failures may lead to serious patient injury or death. (Source: FDA MedWatch)
Source: FDA MedWatch - October 10, 2014 Category: American Health Source Type: news
ICU Medical ConMed Stat2 Flow Controller: Class 1 Recall - Delivers Higher Flow Rate than Intended
Use of the affected product may cause serious adverse health consequences, including death. (Source: FDA MedWatch)
Source: FDA MedWatch - October 10, 2014 Category: American Health Source Type: news
Oregon Compounding Centers, Inc. Unexpired Sterile Products: Recall - Lack of Sterility Assurance
Patients in Oregon and Washington may be at risk of serious infections which may be life threatening. (Source: FDA MedWatch)
Source: FDA MedWatch - October 10, 2014 Category: American Health Source Type: news
Vancomycin Hydrochloride for Injection USP, Equivalent to 1 Gram Vancomycin (Sterile Powder) by Hospira, Inc.: Recall - Uncontrolled Storage During Transit
One lot may have experienced temperature excursions during shipment. (Source: FDA MedWatch)
Source: FDA MedWatch - October 8, 2014 Category: American Health Source Type: news
SAM Junctional Tourniquet Accessory (Axilla) Strap - SAM Medical Products: Recall - Potential Clip Failure
Product failure could cause a potential delay in controlling axilla hemorrhage. (Source: FDA MedWatch)
Source: FDA MedWatch - October 8, 2014 Category: American Health Source Type: news
