-
Vegetable Vigra by Natures Supplement: Recall - Undeclared Drug Ingredient
on September 21, 2017 at 5:00 pm
Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that, taken with this product, could lower blood pressure to dangerous levels that could be life-threatening. […]
-
Ocaliva (obeticholic acid): Drug Safety Communication - Increased Risk of Serious Liver Injury
on September 21, 2017 at 2:00 pm
Reports of Ocaliva being incorrectly dosed in some patients with moderate to severe decreases in liver function. Some patients received a higher frequency of dosing than is recommended in the drug label. […]
-
Rhino 7, Papa Zen, Fifty Shades, and Grande X Dietary Supplements by Gadget Island: Recall - Undeclared Drug Ingredients
on September 20, 2017 at 9:41 pm
Use of products with undeclared active ingredients sildenafil, tadalafil and desmethyl carbodenafil may interact with nitrates and may cause a significant drop in blood pressure that may be life threatening. […]
-
Opioid Addiction Medications in Patients Taking Benzodiazepines or CNS Depressants: Drug Safety Communication - Careful Medication Management Can Reduce Risks
on September 20, 2017 at 4:00 pm
Health care professionals should develop a treatment plan when buprenorphine or methadone is used in combination with benzodiazepines or other CNS depressants. […]
-
Urogynecologic Surgical Mesh Implants by Boston Scientific: Notification – Potential for Counterfeit Raw Material
on September 19, 2017 at 4:00 am
UPDATED 09/19/2017 Updating after extensive review of data and information. […]
-
OriGen VV28F Reinforced Dual Lumen ECMO Catheters: Recall - Potential for Separation of Extension Tube From Hub
on September 13, 2017 at 6:00 pm
Separation could result in required intervention to prevent permanent impairment/damage. […]
-
Diabetes Infusion Sets by Medtronic: Recall - Vent Membrane May be Susceptible to Being Blocked by Fluid
on September 12, 2017 at 4:00 am
May lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia. Posted 09/12/2017 […]
-
Baby Organic Liquid Formula by Garden of Life: Recall - Directions For Use May Be Misinterpreted
on September 8, 2017 at 6:00 pm
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. […]
-
Activase (alteplase) 100mg by Genentech: Recall - Lack of Sterility Assurance
on September 7, 2017 at 4:00 am
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. […]
-
Intra-Aortic Balloon Pumps by Datascope/MAQUET: Class I Recall - False Blood Detection Alarm, Ingress of Fluid Into Pump
on September 6, 2017 at 5:00 pm
If therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including death. […]
-
Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Recommends Separating Dosing
on September 6, 2017 at 1:00 pm
Too much potassium in the blood can cause problems with heart rhythm, which in rare cases can be fatal. […]
-
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
on September 5, 2017 at 7:00 pm
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. […]
-
Alcohol Pads or Benzalkonium Chloride Antiseptic Towelettes by Foshan Flying Medical Products: FDA Alert - Lack of Sterility Assurance and Other Quality Issues
on September 1, 2017 at 4:00 am
The use of these alcohol pads and antiseptic towelettes could cause infections. […]
-
Unexpired Lots of Oxytocin Compounded with Either Lactated Ringers or Lactated Ringers and Dextrose by PharMEDium - Recall - Sub-Potency
on September 1, 2017 at 4:00 am
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. […]
-
Keytruda (pembrolizumab) in Patients with Multiple Myeloma: FDA Statement - Two Clinical Trials on Hold
on August 31, 2017 at 3:00 pm
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. […]
-
Vancomycin Hydrochloride for Injection, USP, 750 mg/vial by Hospira: Recall - Presence of Particulate Matter
on August 31, 2017 at 12:00 pm
If administered to a patient, particulate may result in phlebitis, end-organ granuloma or micro-embolic effects, or gastrointestinal trauma. […]
-
Doctor Manzanilla Cough & Cold and Doctor Manzanilla Allergy & Decongestant Relief Syrup: Recall - Potential Contamination with Burkholderia cepacia
on August 30, 2017 at 11:00 pm
Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threating in patients with compromised immune systems. […]
-
Piyanping Anti-Itch Lotion: Recall - Incorrect Active Ingredient
on August 30, 2017 at 10:00 pm
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. […]
-
Forced Air Thermal Regulating Systems: Healthcare Provider Letter - Information About Use
on August 30, 2017 at 3:00 pm
FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted. […]
-
Implantable Cardiac Pacemakers by Abbott (formerly St. Jude Medical): Safety Communication - Firmware Update to Address Cybersecurity Vulnerabilities
on August 29, 2017 at 5:00 pm
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. […]