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Alerts and Recalls

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  • FDA MedWatch: Oxacillin for Injection, USP, 10g by Sagent - Recall

    Friday, August 19, 2016

    Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of one lot of Oxacillin for Injection, USP, 10 g (NDC 25021-163-99) Lot OXT512 (Exp. Date March 2017) manufactured by Astral SteriTech Private Limited and distributed by Sagent. Sagent initiated this recall to the user level due to the receipt of a product complaint for a single vial containing small, dark particulate matter found within the solution after reconstitution. The particulate matter has been identified as iron oxide.

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  • Newly Released Treatment of Drug-Susceptible Tuberculosis (TB) Guidelines

    Thursday, August 18, 2016

    Although tuberculosis (TB) is no longer a leading cause of death in the United States, efforts to eliminate this potentially fatal disease are critical. After two decades of steady decline, the number of reported U.S. TB cases rose slightly in 2015 to 9,563, according to provisional data released by CDC.

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  • AKF Press Release: Disaster Relief Program Activated to Help Kidney Patients Affected by Floods in LA and MS

    Wednesday, August 17, 2016

    The American Kidney Fund (AKF), the nation’s leading provider of charitable assistance to people with kidney failure, has activated its Disaster Relief Program to help dialysis patients affected by the devastating flooding in Louisiana and Mississippi.

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  • FDA:MedWatch - July 2016 Safety Labeling Changes

    Monday, August 15, 2016

    The MedWatch July 2016 Safety Labeling Changes posting includes 52 products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE.

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  • FDA Company Announcement: PharmaTech LLC Issues Voluntary Nationwide Recall

    Monday, August 8, 2016

    PharmaTech, LLC of Davie, FL, is voluntarily recalling all liquid products from October 20, 2015 through July 15, 2016 as a precautionary measure due to a potential risk of product contamination with Burkholderia cepacia.

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  • Amikacin Sulfate Injection USP 500 mg/2 mL (250 mg/mL) and 1 Gram/4 mL (250 mg/mL) Vials by Teva: Recall - Glass Particulate Matter

    Wednesday, August 3, 2016

    Teva Pharmaceuticals announced a voluntary recall of seven lots of Amikacin sulfate Injection USP, 500 mg/2mL (250 mg/mL) and 1 gram/4mL (250 mg/mL) vials due to the potential for the presence of glass particulate matter. The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening if a critical organ is affected.

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  • CDC Guidance for Travel and Testing of Pregnant Women for Zika

    Tuesday, August 2, 2016

    The Florida Department of Health (FL DOH) has identified an area with local mosquito-borne Zika virus transmission (active Zika virus transmission) in Miami. Based on the earliest time of symptom onset and a maximal two-week incubation period for Zika virus, this guidance applies to women of reproductive age and their partners who live in or traveled to this area after June 15, 2016.

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  • 2016 DOHMH Advisory #26: Tick-borne Disease Advisory

    Monday, August 1, 2016

    New York City (NYC) clinicians should be on the alert for patients with tick-borne diseases. This advisory presents key epidemiologic findings regarding reportable tick-borne diseases (TBD) in NYC and reminds clinicians of reporting requirements.

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  • FDA: Saety Alert - Comfort Shield Barrier Cream Cloths by Sage Products -Recall

    Monday, August 1, 2016

    Sage Products is voluntarily initiating a nationwide recall of one lot of Comfort Shield Barrier Cream Cloths to the distributor and health care facility/user level. The recall is being initiated due to product contamination with the bacteria, Burkholderia cepacia. Topical administration of a product with B. cepacia may cause serious infections in patients whose bodies cannot fight disease or in hospitalized patients, as well as certain other patient groups. These infections could be life-threatening.

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  • Fluoroquinolone Antibacterial Drugs for Systemic Use: Drug Safety Communication – Warnings Updated Due to Disabling Side Effects

    Wednesday, July 27, 2016

    FDA approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, FDA revised the Boxed Warning, FDA’s strongest warning, to address these serious safety issues. In addition, FDA updated other parts of the drug label including the Warnings and Precautions and Medication Guide sections.

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