Glenmark Pharmaceuticals Inc., USA Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

Summary Company Announcement Date: December 17, 2019 FDA Publish Date: December 17, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA (Nitrosodimethylamine) impurity Company Name: Glenmark Pharmaceuticals, Inc. Brand Name: Brand Name(s) Product Description: Product Description Ranitidine Tablets 150mg and 300mg Company Announcement Glenmark Pharmaceutical Inc., USA (“Glenmark”) today announced the voluntary recall…

GE Healthcare Recalls Giraffe Incubators and OmniBeds Due to Potential for Infants to Fall

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, Giraffe OmniBed Carestation. All Giraffe Incubators and Giraffe OmniBeds Manufacturing Dates: April 2008 to September 2019 Distribution Dates: April 2000…

Medtronic Recalls SynchroMed II Implantable Drug Infusion Pump Due to the Potential Presence of Foreign Particles Inside the Pump Motor Assembly Which May Lead to a Pump Motor Stall

Recalled Product SynchroMed II pump, Model numbers 8637-20 and 8637-40 Manufacturing Dates: May 4, 2018 to April 5, 2019 Distribution Dates: May 11, 2018 to September 5, 2019 Devices Recalled in the U.S.: 7,317 Date Initiated by Firm: October 9, 2019 Device Use The Medtronic SynchroMed II implantable drug infusion pump, part of the SynchroMed…

Having Naloxone on Hand Can Save a Life During an Opioid Overdose

Image Anyone can save a life during an opioid overdose with naloxone, a front-line defense in the nation’s opioid crisis. Naloxone is a life-saving drug that, when sprayed into the nose or injected, quickly reverses the powerful effects of opioids during an overdose. Everyone who overdoses with opioids, whether it is with a prescribed medicine…

Public Safety Alert Due to Marketing of Unapproved Stem Cell and Exosome Products

[Posted 12/09/2019] AUDIENCE: Health Professional, Patient, Consumer, Risk Manager ISSUE: FDA is informing the public, especially patients, health care practitioners, and clinics, of multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes. FDA is carefully assessing this situation along with our federal…

Don’t Double Up on Acetaminophen

 Subscribe: FDA Consumer Health Information Español You have flu symptoms, so you’ve been getting some relief for the past two days by taking a cough and flu medicine every few hours. Late in the day, you have a headache and you think about grabbing a couple of acetaminophen tablets to treat the pain. Stop right…

FDA-Approved Devices That Help Keep the Heart Beating

Image Español Heart disease, also called cardiovascular disease, can have serious consequences. It’s the leading cause of death for men and women in the United States. Medical devices approved by the U.S. Food and Drug Administration (FDA), such as pacemakers and defibrillators, have extended and improved the lives of millions of people living with heart…

Vaccines, Blood & Biologics

From blood to vaccines, FDA protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. Read these Consumer Updates to learn more.     Content current as of: 04/22/2019 Regulated Product(s) Article source: http://www.fda.gov/consumers/consumer-updates/vaccines-blood-biologics

Food Safety Tips for Healthy Holidays

Image Español Parties, family dinners, and other gatherings where food is served are all part of the holiday cheer. But the merriment can change to misery if food makes you or others ill. Typical symptoms of foodborne illness are vomiting, diarrhea, and flu-like symptoms, which can start anywhere from hours to days after contaminated food…