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Important Information on the Use of Serological (Antibody) Tests for COVID-19 – Letter to Healthcare Providers

The U.S. Food and Drug Administration (FDA) recommends that healthcare providers continue to use serological tests intended to detect antibodies to SARS-CoV-2 to help identify people who may have been exposed to the SARS-CoV-2 virus or have recovered from the COVID-19 infection. Healthcare providers should also be aware of the limitations of these tests and

By | April 27th, 2020|alerts|0 Comments

Severe Illness Associated with Using Non-Pharmaceutical Chloroquine Phosphate to Prevent and Treat Coronavirus Disease 2019 (COVID-19)

Summary Chloroquine phosphate, when used without a prescription and supervision of a healthcare provider, can cause serious health consequences, including death. Clinicians and public health officials should discourage the public from misusing non-pharmaceutical chloroquine phosphate (a chemical used in home aquariums). Clinicians should advise patients and the public that chloroquine, and the related compound hydroxychloroquine,

By | April 2nd, 2020|alerts|0 Comments

BodyGuard Infusion Pump System by CME America – Class I Recall

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 BodyGuard Infusion Pump Systems All Serial Numbers of Affected Model Numbers Model Numbers: BG 323 Pump* BodyGuard 121 Twins Pump* BodyGuard 545 ColorVision Pump * BodyGuard 575

By | April 2nd, 2020|alerts|0 Comments

Class II Recall of Ten Lots of the Revaclear Capillary Dialyzer 300, Product Code 114745L

The FDA has announced the Class II recall of ten lots of the Revaclear Capillary Dialyzer 300, product code 114745L, UDI 07332414123055, because of possible particulate matter inclusions.  Lot Numbers are C419124901, C419125001, C419125101, C419125201, C419125401, C419125501, C419125601, C419125801, C419126001, and C419126401. Learn More

By | March 16th, 2020|alerts|0 Comments

Cybersecurity Updates Affecting Medtronic Implantable Cardiac Device Programmers: FDA Safety Communication

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 these vulnerabilities is already publicly

By | October 9th, 2019|alerts|0 Comments

Fresenius Kabi Recalls Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library

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 Volumat MC Agilia Infusion System and Vigilant Drug LibraryModelsVolumat MC Agilia Z021135, Software Versions 1.7 and 1.9aVigilant Drug Library Z073476, Software Versions 1.0 and 1.1Lot Numbers: AllManufacturing

By | August 15th, 2019|alerts|0 Comments

Par Pharmaceutical, Inc. Issues Voluntary Nationwide Recall of One Lot of Mycophenolate Mofetil for Injection

Endo International plc, announced today that one of its operating companies, Par Pharmaceutical, Inc., is voluntarily recalling one lot of Mycophenolate Mofetil for Injection, USP to the hospital and retail pharmacy level. One vial of product was observed containing a glass fragment after reconstitution. The administration of a glass particulate, if present in an intravenous

By | May 8th, 2019|alerts|0 Comments

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall

Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s

By | December 3rd, 2018|alerts|0 Comments

Hospira Issues Voluntary Nationwide Recall

Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions. Daptomycin for Injection has been associated with reports of adverse events indicative of

By | July 18th, 2018|alerts|0 Comments