[Posted 04/20/2017] AUDIENCE: Pediatrics, OB/GYN, Internal Medicine ISSUE: FDA is restricting the use of codeine and tramadol medicines in children. These medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used…

Including Uproar, Cummor, Zrect, LabidaMAX, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, Enhancerol Natural Male Enhancement capsules [Posted 04/19/2017] AUDIENCE: Consumer ISSUE: Organic Herbal Supply, Inc. announced that it is conducting a voluntary nationwide recall of all lots of Uproar, Cummor, Zrect, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, Enhancerol…

UPDATED 04/13/2017. FDA is alerting consumers of a nationwide voluntary recall of all lots of Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets by the manufacturer, Standard Homeopathic Company, which is located in Los Angeles. On April 10, the company received FDA’s formal recall request and agreed to conduct…

[Posted 04/08/2017] AUDIENCE: Neurology, Surgery ISSUE: Medtronic announced that on February 22, 2017 it notified customers of a voluntary recall of all unused units of the StrataMR adjustable valves and shunts. Medtronic is conducting this voluntary recall due to an issue that can occur post-implantation that can lead to the…

[Posted 04/06/2017] AUDIENCE: Patient, Pharmacy ISSUE: Isomeric Pharmacy Solutions (“Isomeric”) is voluntarily recalling all lots of sterile products compounded and packaged by Isomeric and that remain within expiry to the hospital/user level because of FDA concerns of a lack of sterility assurance. These concerns were brought to Isomeric’s attention during…

[Posted 04/05/2017] AUDIENCE: Risk Manager, Pulmonology, Nursing ISSUE: Medtronic notified customers worldwide of a voluntary field corrective action for all its Newport HT70 and Newport HT70 Plus ventilators manufactured since 2010. The voluntary field corrective action is being conducted following reports that the ventilator may reset spontaneously during normal operation,…

[Posted 03/31/2017] AUDIENCE: Consumer, Pharmacy ISSUE: Mylan N.V. announced that Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for EpiPen Auto-Injector, has expanded a voluntary recall of select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr (epinephrine injection, USP) Auto-Injectors to now include additional lots distributed in…

[Posted 03/31/2017] AUDIENCE: Risk Manager, Surgery, Cardiology, Nephrology ISSUE: Merit Medical Systems Inc. is recalling the Prelude Short Sheath Introducer due to a manufacturing defect which may cause the tip to separate from the sheath during the insertion procedure. If this occurs, the tip could enter the patient’s bloodstream. This…

[Posted 03/30/2017] AUDIENCE: Consumer ISSUE: Envy Me is recalling LaBri’s Body Health Atomic, dietary supplement marketed for weight loss, sold in 60 capsule, plastic bottles. The recall includes all lot codes, manufacturing codes and expiration dates.  The FDA analyzed samples of La Bri’s Body Health Atomic and found it to contain…

[Posted 03/24/2017] AUDIENCE: Risk Manager, Emergency Medicine ISSUE: Phillips is recalling the HeartStart MRx Monitor/Defibrillator due to electrical and battery connection issues that may prevent the device from powering up, charging, and delivering an electrical shock therapy. The device may also unexpectedly stop pacing. A delay in delivering therapy could…