header”></head>

<body class=

4e Brands North America Issues Nationwide Voluntary Recall of Hand Sanitizer

San Antonio, Texas, 4e Brands North America is voluntarily recalling ten (10) bottle sizes of Hand Sanitizers to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the

By | July 15th, 2020|alerts|0 Comments

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

The U.S. Food and Drug Administration (FDA) recommends that health care 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. Health care providers should also be aware of the limitations of these

By | June 29th, 2020|alerts|0 Comments

Remdesivir by Gilead Sciences: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of Treatment

AUDIENCE: Health Professional, Pharmacy, Patient ISSUE: FDA is warning health care providers that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir. The agency is not aware of instances of this reduced activity occurring in the clinical setting but, is continuing to evaluate all

By | June 17th, 2020|alerts|0 Comments

Amneal Pharmaceuticals LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, Due to Detection of N-Nitrosodimethylamine (NDMA) Impurity

Amneal Pharmaceuticals LLC Bridgewater, New Jersey (Amneal), is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, within expiry to the Retail Level. Amneal was notified by the U.S. FDA that the Agency’s testing of seven lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750

By | June 4th, 2020|alerts|0 Comments

Use the Correct Cycle and Compatible N95 Respirators When Decontaminating Respirators with STERRAD Sterilization Systems – Letter to Health Care Providers

The U.S. Food and Drug Administration (FDA) reminds reprocessing staff in health care facilities to use the correct decontamination cycle associated with certain models of the Advanced Sterilization Products (ASP) STERRAD Sterilization Systems and to only decontaminate compatible N95 or N95-equivalent respirators for reuse during the COVID-19 pandemic. ASP STERRAD Sterilization Systems use vaporized hydrogen

By | May 30th, 2020|alerts|0 Comments

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