FDA Medwatch : Pasta De Lassar Andromaco Skin Protectant 25 Percent Zinc Oxide by MarcasUSA: Recall - Potential Contamination

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AUDIENCE: Consumer, Pediatrics

ISSUE: MarcasUSA, LLC and Industria Farmacéutica Andromaco, S.A. de C.V. voluntarily recalled four lots of Pasta De Lassar Andromaco Skin Protectant, 25% zinc oxide to the retail level. FDA analysis of this product confirmed that Pasta De Lassar Andromaco is contaminated with high levels of yeast, mold, and bacteria. The specific lot associated to the positive findings was never sold in the US. However, due to the amount and type of contamination the remaining four lots in the US market are being recalled out of an abundance of caution.

FDA Medwatch : Kratom-containing Products by Triangle Pharmanaturals: Mandatory Recall - Risk of Salmonella

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AUDIENCE: Consumer

ISSUE: FDA issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several were found to contain salmonella. The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall.

FDA Medwatch : Coastal Meds Recall of All Products Marketed as Sterile

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AUDIENCE: Pharmacy, Nursing, Risk Manager

ISSUE: FDA is alerting health care professionals to a voluntary recall of all non-expired products marketed as sterile made by Coastal Meds due to visible particles in some of the drug vials for injection.

BACKGROUND: During FDA’s recent inspection of Coastal Meds, investigators observed visible particulates and poor sterile production practices which further raise concerns about particulates in Coastal Meds’ drug products intended for injection.

FDA Medwatch : Certain Implantable Cardiac Devices by Abbott (formerly St. Jude Medical): FDA Safety Communication - Battery Performance Alert and Cybersecurity Firmware Updates

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AUDIENCE: Cardiology

ISSUE: On April 11, 2018, the FDA approved a firmware update that is now available and is intended as a corrective action (recall), to reduce the risk of patient harm due to premature battery depletion and potential exploitation of cybersecurity vulnerabilities for certain Abbott ICDs and CRT-Ds. "Firmware" is a specific type of software embedded in the hardware of a medical device (e.g. a component in the defibrillator).

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