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August 2017

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  • Lorazepam Oral Concentrate, USP 2mg/mL by Amneal Pharmaceuticals: Recall - Misprinted Dosing Droppers

    Wednesday, August 16, 2017
    Amneal Pharmaceuticals LLC is voluntarily recalling 13 lots of Lorazepam Oral Concentrate, USP 2mg/mL, to the Consumer level due to a defect in the dropper markings. The Lorazepam Oral Concentrate, USP 2mg/mL, product is packaged with a dosing dropper, supplied to Amneal by a third party.

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  • Pravastatin Sodium Tablets by International Laboratories: Recall - Mislabeling

    Friday, August 11, 2017
    International Laboratories, LLC is voluntarily recalling one (1) Lot of Pravastatin Sodium Tablets USP 40 mg packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg...

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  • Liquid Drug Products Manufactured by PharmaTech and Distributed by Rugby Laboratories and Possibly Other Companies: FDA Advisory - Not to Use

    Thursday, August 10, 2017
    FDA is advising health care professionals and patients not to use any liquid product manufactured by PharmaTech LLC, Davie, Florida, due to Burkholderia cepacia contamination and the potential for severe patient infection. Rugby Laboratories, Livonia, Michigan, announced a voluntary recall on...

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  • Increase in Reported cases of Cyclospora cayetanensis Infection, United States, Summer 2017

    Monday, August 7, 2017
    The Centers for Disease Control and Prevention (CDC), State and Local Health Departments, and the Food and Drug Administration (FDA) are investigating an increase in reported cases of cyclosporiasis. The purpose of this HAN Advisory is to notify public health departments and healthcare facilities...

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  • Diocto Liquid and Diocto Syrup by Rugby Laboratories: Recall - Possible Product Contamination

    Thursday, August 3, 2017
    Rugby Laboratories is voluntarily recalling all lots of Diocto Liquid and Diocto Syrup, (docusate sodium solutions) manufactured by PharmaTech, LLC due to a risk of product contamination with Burkholderia cepacia. FDA informed Rugby that it received several adverse event reports of B. cepacia...

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