Summary Company Announcement Date: November 19, 2019 FDA Publish Date: November 19, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDA Company Name: Precision Dose Inc. Brand Name: Brand Name(s) PrecisionDose Product Description: Product Description Ranitidine Oral Solution, USP 150 mg/10 mL Company…
Mondelēz Global LLC Conducts Voluntary Recall of Limited Quantity of Cheese Nips (11 oz. Box) Product in the U.S. Due to Potential Presence of Foreign Material
Summary Company Announcement Date: November 15, 2019 FDA Publish Date: November 20, 2019 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential presence of plastic Company Name: Mondelēz Global LLC Brand Name: Brand Name(s) Product Description: Product Description Cheese Nips Company Announcement Mondelēz Global LLC announced today a voluntary recall of a…
Update On Device Failure Associated with Getinge’s Maquet/Datascope Intra-Aortic Balloon Pumps – Letter to Health Care Providers
November 19, 2019 The U.S. Food and Drug Administration (FDA) is providing an update on our evaluation of device failures associated with Getinge’s Maquet/Datascope intra-aortic balloon pump (IABP) devices: Cardiosave (Hybrid and Rescue), CS300 and CS100/CS100i. In our previous letter to health care providers, the FDA informed providers about reports of Maquet/Datascope IABP devices shutting…
Device Failure Associated with Getinge’s Maquet/Datascope Intra-Aortic Balloon Pumps – Letter to Health Care Providers
November 1, 2018 Dear Cardiologists, Cardiothoracic Surgeons, Anesthesiologists, Nurses, Critical Care Specialists and Biomedical Engineers: We are writing to inform you that the FDA is evaluating recent reports of Getinge’s Maquet/Datascope intra-aortic balloon pump (IABP) devices shutting down while running on battery power. These devices are used on critically-ill patients in health care facilities, including…
Select Varieties of Breakstone’s Cottage Cheese are Voluntarily Being Recalled Due to Potential Presence of Foreign Material
Summary Company Announcement Date: November 15, 2019 FDA Publish Date: November 15, 2019 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential presence of plastic and metal Company Name: Kraft Heinz Foods Company Brand Name: Brand Name(s) Breakstone’s Product Description: Product Description Cottage Cheese Company Announcement Select varieties of Breakstone’s Cottage Cheese…
Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Ranitidine Hydrochloride 150mg and 300mg Capsules (Manufactured by Novitium Pharma LLC) Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)
Summary Company Announcement Date: November 15, 2019 FDA Publish Date: November 15, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDA Company Name: GSMS, Inc. Brand Name: Brand Name(s) GSMS Incorporated Product Description: Product Description Ranitidine HCl 150mg and 300mg Capsules Company Announcement…
Is It a Cold or the Flu? Prevention, Symptoms, Treatments
Warning Signs of Severe Flu Seek medical care if you aren’t getting any better. Signs of trouble can include: In children: Fast breathing or trouble breathing Bluish skin color Not drinking enough fluids Not waking up or not interacting Being so irritable that the child does not want to be held Flu-like symptoms improve but…
Philips Medical Systems (Cleveland) Recalls Forte Gamma Camera System Due to Potential for the Detector to Drop
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 Philips Medical System (Cleveland) Forte Gamma Camera System Forte (882020) Forte Jetstream (882290) Forte Jetstream upgrade (882291) Forte Jetstream AZ (882320) Forte Jetstream AZ upgrade (882321) Diamond…
Natural Grocers Issues Recall on Organic Soybeans Due to Mold
Summary Company Announcement Date: November 13, 2019 FDA Publish Date: November 13, 2019 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential to contain mold Company Name: Vitamin Cottage Natural Food Markets, Inc. Brand Name: Brand Name(s) Natural Grocers Product Description: Product Description Organic Soybeans Company Announcement Vitamin Cottage Natural Food Markets,…
Nature’s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10 Male Enhancement Capsules due to an Undeclared PDE-5 Inhibitor Found in The Product
Summary Company Announcement Date: November 13, 2019 FDA Publish Date: November 13, 2019 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Due to unapproved active ingredient (sildenafil) Company Name: Nature’s Rx Brand Name: Brand Name(s) Silver Bullet Product Description: Product Description Male Enhancement Capsules Company Announcement Nature’s Rx is voluntarily recalling lot: 01251ZX1,…