Posts for tag: Recalls
600,000 Albuterol Inhalers Recalled
GlaxoSmithKline is recalling more than 590,000 albuterol inhalers. Three lots of Ventolin HFA 200D inhalers have been voluntarily recalled due to a potential issue with the delivery system, a spokesman for the British pharmaceutical company said.
The affected lot numbers are 6ZP0003, 6ZP9944 and 6ZP9848. The devices have been recalled from hospitals, pharmacies, retailers and wholesalers in the United States.
"There is possible risk that the affected inhalers could potentially not deliver the stated number of actuations," spokesman Juan Carlos Molina wrote in an email. "We continue to investigate the issue in order to identify the root cause and implement appropriate corrective and preventative actions."
It's not a patient-level recall, but patients whose inhalers are among the affected lots can contact GSK's customer service center at 1-888-825-5249 with questions. If the devices are not relieving symptoms, patients should seek medical treatment right away.
When functioning properly, the metered-dose inhaler releases a fixed dose of medication in aerosol form.
Metered-dose albuterol inhalers are used to deliver medication into the body through the airway and lungs. Albuterol opens airways in the lungs to treat common conditions such as asthma and chronic obstructive pulmonary disease.
FDA confirms elevated toxin levels in homeopathic teething tablets
Sanofi US Recalls All Auvi-Q Epinephrine Injection in 2015;
Available Again in 2017!
Sanofi US is voluntarily recalling all of its epinephrine injection (Auvi-Q) on the market because patients taking it for life-threatening anaphylaxis may receive an inaccurate and inadequate dose, the US Food and Drug Administration (FDA) announced today.
The company has received 26 unconfirmed reports of suspected device malfunction from patients in the United States and Canada as of October 26. No one died as a result, but patients continued to experience symptoms of underlying hypersensitivity reaction, the FDA said in a news release.
The agency said that patients using Auvi-Q should ask their physician to prescribe an alternate epinephrine autoinjector. If patients experience anaphylaxis, they should only use Auvi-Q if no other epinephrine autoinjector is available, and then seek emergency medical care.
Auvi-Q is distributed in packs that contain two active injectors, along with a training injector. There are roughly 490,000 packs of Auvi-Q on the market, all of them subject to the recall, Paul Chew, MD, Sanofi's global chief medical officer, told Medscape Medical News. Some packs contain epinephrine injection at 0.15 mg strength, and others at 0.3 mg strength.
The recall includes Auvi-Q packs in lots numbered 2299596 through 3037230, which expire March 2016 through December 2016.
Sanofi customers with questions about the voluntary recall, including how to return the product, can go to the Auvi-Q website or call 1-866-726-6340. More information about the recall is available on the FDA website.
To report any problems with Auvi-Q epinephrine injection, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online athttps://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.