PRODUCT SAFETY

MedWatch, The FDA Safety Information and Adverse Event Reporting Program

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Chlorhexidine Gluconate: Drug Safety Communication - Rare But Serious Allergic Reactions

FDA is warning that rare but serious allergic reactions have been reported with the widely used skin antiseptic products containing chlorhexidine gluconate. Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years. As a result, FDA is requesting the manufacturers of over-the-counter (OTC) antiseptic products containing chlorhexidine gluconate to add a warning about this risk to the Drug Facts labels. More information

Halo One Thin-Walled Guiding Sheath by Bard Peripheral Vascular Inc.: Class I Recall - Sheath Separation, Kinking, or Tip Damage

Bard Peripheral Vascular Inc. is recalling the Halo One Thin-Walled Guiding Sheath because the sheath body may separate from the sheath hub while removing the device from the patient's leg. The company also reports that the sheath may kink, and that its tip may become damaged during the procedure. The use of affected sheaths may result in prolonged procedure times and on additional surgical intervention to remove detached components from the patient. The affected product may cause other serious adverse health consequences such as internal tears and perforation to arteries or veins, excessive bleeding, and death. More information

NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents by bioMerieux: Recall - Potential Inaccurate Test Results

BioMerieux is recalling the NucliSENS reagents and accessory products due to a quality problem of the magnetic silica (MagSil) component. MagSil is used to extract and purify genetic material from patient samples. Kits with the affected lots of the magnetic silica may not be able to fully extract nucleic acids from the sample and detect infection or provide proper diagnosis. The detection problem could lead to a risk of false negative results, invalid results, or under-quantification for clinical laboratory tests. This error may result in inappropriate treatment or delay in treatment. The use of the affected product may cause serious adverse health consequences, including death. More information

Vancomycin Hydrochloride for Injection, USP by Hospira: Recall - Particulate Matter in Vial

Hospira, Inc. is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP (NDC: 0409-6510-01, Lot 591053A, Expiry Date 1NOV2017), to the hospital/retail level due to a confirmed customer report for the presence of particulate matter within a single vial. The product is packaged in a carton containing 1x100 mL vial. The lot was distributed from August 2016 through September 2016 in the United States. More information

Certain Homeopathic Teething Products: FDA Warning- Confirmed Elevated Levels of Belladonna

FDA announced that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products. More information

For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch, The FDA Safety Information and Adverse Event Reporting Program