Summary Company Announcement Date: September 25, 2019 FDA Publish Date: September 25, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) Company Name: Apotex Corp. Brand Name: Brand Name(s) Apotex Corp. Product Description: Product Description Ranitidine Tablets 75mg and 150mg Company Announcement Apotex Corp. is voluntarily, on…
Mavidon Issues Voluntary Worldwide Recall of LemonPrep® Tubes and Single Use Cups
Summary Company Announcement Date: September 26, 2019 FDA Publish Date: September 26, 2019 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Burkholderia cepacia Company Name: Mavidon Brand Name: Brand Name(s) Product Description: Product Description Skin prepping lotion for enhancement of signal quality at electrode site Company Announcement Mavidon is voluntarily recalling 21 lots…
URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices: FDA Safety Communication
Date Issued: October 1, 2019 The U.S. Food and Drug Administration (FDA) is informing patients, health care providers and facility staff, and manufacturers about cybersecurity vulnerabilities that may introduce risks for certain medical devices and hospital networks. The FDA is not aware of any confirmed adverse events related to these vulnerabilities. However, software to exploit…
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…
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…
Zantac (ranitidine): Safety Information – NDMA Found in Samples of Some Ranitidine Medicines
[Posted 09/13/2019] AUDIENCE: Consumer, Patient, Health Professional, Pharmacy ISSUE: FDA has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory…