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FDA MedWatch Safety Alerts
Updated: 3 min 13 sec ago

Urogynecologic Surgical Mesh Implants by Boston Scientific: Notification – Potential for Counterfeit Raw Material

11 hours 28 min ago
UPDATED 09/19/2017 Updating after extensive review of data and information.
Categories: Health News - Safety

OriGen VV28F Reinforced Dual Lumen ECMO Catheters: Recall - Potential for Separation of Extension Tube From Hub

Wed, 09/13/2017 - 23:30
Separation could result in required intervention to prevent permanent impairment/damage.
Categories: Health News - Safety

Diabetes Infusion Sets by Medtronic: Recall - Vent Membrane May be Susceptible to Being Blocked by Fluid

Tue, 09/12/2017 - 09:30
May lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia. Posted 09/12/2017
Categories: Health News - Safety

Baby Organic Liquid Formula by Garden of Life: Recall - Directions For Use May Be Misinterpreted

Fri, 09/08/2017 - 23:30
If not administered precisely following the labeled instructions, the product may present difficulties in swallowing and potentially pose a choking hazard due to the thickness of the liquid.
Categories: Health News - Safety

Activase (alteplase) 100mg by Genentech: Recall - Lack of Sterility Assurance

Thu, 09/07/2017 - 09:30
The use of impacted Sterile Water for Injection could result in adverse events such as fever, chills, phlebitis, and granuloma or more severe adverse events such as sepsis or invasive systemic infections.
Categories: Health News - Safety

Intra-Aortic Balloon Pumps by Datascope/MAQUET: Class I Recall - False Blood Detection Alarm, Ingress of Fluid Into Pump

Wed, 09/06/2017 - 22:30
If therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including death.
Categories: Health News - Safety

Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Recommends Separating Dosing

Wed, 09/06/2017 - 18:30
Too much potassium in the blood can cause problems with heart rhythm, which in rare cases can be fatal.
Categories: Health News - Safety

Hydromorphone HCl Injection, USP 2 mg/mL, and Levophed (Norepinephrine Bitartrate Injection, USP) 4 mg/4 mL (1 mg/mL) Vial by Hospira: Recall - Lack of Sterility Assurance

Wed, 09/06/2017 - 00:30
If impacted product is administered to a patient, adverse events ranging from fever, chills, and malaise, to severe adverse events such as septicemia, bacterial meningitides and wound infection could occur.
Categories: Health News - Safety

Unexpired Lots of Oxytocin Compounded with Either Lactated Ringers or Lactated Ringers and Dextrose by PharMEDium - Recall - Sub-Potency

Fri, 09/01/2017 - 09:30
An extreme and unexpected reduction in dose than expected could lead to a delay in treatment, disruption of clinical care of the patient, and worsening of patient's conditions.
Categories: Health News - Safety

Keytruda (pembrolizumab) in Patients with Multiple Myeloma: FDA Statement - Two Clinical Trials on Hold

Thu, 08/31/2017 - 20:30
Risks associated with the use of Keytruda in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma.
Categories: Health News - Safety

Vancomycin Hydrochloride for Injection, USP, 750 mg/vial by Hospira: Recall - Presence of Particulate Matter

Thu, 08/31/2017 - 17:30
If administered to a patient, particulate may result in phlebitis, end-organ granuloma or micro-embolic effects, or gastrointestinal trauma.
Categories: Health News - Safety

Doctor Manzanilla Cough & Cold and Doctor Manzanilla Allergy & Decongestant Relief Syrup: Recall - Potential Contamination with Burkholderia cepacia

Thu, 08/31/2017 - 04:30
Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threating in patients with compromised immune systems.
Categories: Health News - Safety

Piyanping Anti-Itch Lotion: Recall - Incorrect Active Ingredient

Thu, 08/31/2017 - 03:30
There is a reasonable probability of the following side effects of topical steroids which include but are not limited to skin changes, adrenal suppression, glaucoma, and cataracts.
Categories: Health News - Safety

Forced Air Thermal Regulating Systems: Healthcare Provider Letter - Information About Use

Wed, 08/30/2017 - 20:30
FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted.
Categories: Health News - Safety

Implantable Cardiac Pacemakers by Abbott (formerly St. Jude Medical): Safety Communication - Firmware Update to Address Cybersecurity Vulnerabilities

Tue, 08/29/2017 - 22:30
Vulnerabilities, if exploited, could allow an unauthorized user to access patient's device, which could result in patient harm from rapid battery depletion or administration of inappropriate pacing.
Categories: Health News - Safety

Zenith Alpha Thoracic Endovascular Graft by Cook Medical: Recall Correction and Removal of Specific Sizes from Market - Increased Reports of Graft Thrombosis and Occlusion in BTAI Treatment

Mon, 08/28/2017 - 09:30
Correction removed the indication for BTAI; Voluntary recall includes Zenith Alpha Thoracic products in sizes of 18-22mm, including the 26-22mm tapered device.
Categories: Health News - Safety

Ninjacof and Ninjacof A: Recall - Potential Burkholderia Cepacia Contamination

Wed, 08/23/2017 - 21:45
Use of a product that may contain B. cepacia could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.
Categories: Health News - Safety

Sterile Drug Products by Bella Pharmaceuticals: Recall - Lack of Sterility Assurance

Sat, 08/19/2017 - 01:00
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Categories: Health News - Safety

Zenith Alpha Thoracic Endovascular Graft by Cook Medical: Class I Recall - Potential Formation of Thrombus Inside Device

Wed, 08/16/2017 - 21:30
Thrombus may form inside the device after implantation. Thrombosis or occlusion may lead to serious adverse health consequences, including death.
Categories: Health News - Safety

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