Image CaptionForensic Chemistry Center scientists using devices in the analysis of vaping fluid samples. The U.S. Food and Drug Administration’s mission to protect the public health often depends on the agency’s laboratories being able to quickly and accurately analyze samples and to report those results for regulatory action. FDA’s Forensic Chemistry Center serves as the…
Innoveix Pharmaceuticals, Inc. Issues Voluntary Recall of all Sterile Compounded Drug Products Due to a Lack of Sterility Assurance
Summary Company Announcement Date: October 10, 2019 FDA Publish Date: October 10, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential lack of sterility assurance Company Name: Innoveix Pharmaceuticals, Inc. Brand Name: Brand Name(s) Innoveix Pharmaceuticals, Inc. Product Description: Product Description Injectable Human Chorionic Gonadotropin (HCG) and injectable Sermorelin w/GHRP2 Company Announcement Innoveix…
CBER FY 2018 Recall Postings
Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or…
ICU Medical Issues a Voluntary Nationwide Recall of Certain Lots of Plum and Sapphire Microbore Infusion Sets with Inline Filters
Summary Company Announcement Date: October 04, 2019 FDA Publish Date: October 08, 2019 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for small amounts of fluid leaking out of the air vents on the inline filters Company Name: ICU Medical, Inc. Brand Name: Brand Name(s) Plum and Sapphire Product Description: Product Description…
Help the FDA Prevent Kids from Using Tobacco
Help keep kids smiling—and tobacco-free. Report tobacco sales violations to the FDA. Español Because teens’ brains are still developing, it may be easier for them to become addicted to nicotine. In fact, as little as one cigarette a month is all it takes for some teens to become addicted, so it’s important to keep tobacco…
Medtronic Recalls 6 French Sherpa NX Active Guide Catheters Due to Separation and Fragmentation Issue
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 6 French Sherpa NX Active Guide Catheters Model numbers: All models Manufacturing Dates: March 10, 2017 to March 14, 2019 Distribution Dates: April 3, 2017 to April…
CBER FY 2019 Recall Postings
Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or…
Lung Injury Update: FDA Warns Public to Stop Using Tetrahydrocannabinol (THC)-Containing Vaping Products and Any Vaping Products Obtained Off the Street
[Posted 10/04/2019] AUDIENCE: Consumer, Health Professional, Pulmonology ISSUE: The FDA is strengthening its warning to consumers to stop using vaping products containing THC amid more than 1,000 reports of lung injuries—including some resulting in deaths—following the use of vaping products. BACKGROUND: Over the past several weeks, the FDA has been working tirelessly along with the…
Vaping Illness Update: FDA Warns Public to Stop Using Tetrahydrocannabinol (THC)-Containing Vaping Products and Any Vaping Products Obtained Off the Street
Image Audience: Consumers and family members of consumers who use vaping products containing tetrahydrocannabinol (or THC), a psychoactive component of the marijuana plant. Consumers who have used vaping products of any kind obtained off the street or from unknown sources. Consumers experiencing symptoms such as cough, shortness of breath or chest pain after using vaping…
Making Sure Kids Are Prepared if They Need Epinephrine Treatments in School
Image Kids are back to school, which, for many parents, means making sure epinephrine prescription products are available and ready to use when needed—including during the school day. The U.S. Food and Drug Administration (FDA) wants to make sure patients, parents, health care providers, school nurses, and pharmacists have the most updated information about the availability of…