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December 2018

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  • Terrific Care, LLC. / Medex Supply Dist, Inc. issues Nationwide Recall of CoaguChek Test Strips

    Thursday, December 27, 2018

    This announcement clarifies information included in Terrific Care, LLC's press release issued on 12/19/2018

    On 12/19/2018, Terrific Care, LLC. / Medex Supply Dist, Inc. initiated a nationwide recall of Roche CoaguChek test strips distributed directly to U.S. consumers by Terrific Care, LLC. / Medex Supply Dist, Inc. This recall only includes CoaguChek test strips distributed directly to U.S. consumers by Terrific Care, LLC. / Medex Supply Dist, Inc via its website/phone calls/facsimal of All Catalog/REF Numbers that DO NOT END IN 160.

    The products distributed by Terrific Care, LLC / Medex Supply Dist, Inc. have been found to inaccurately report high INR test results. Patients taking warfarin who receive inaccurate INR results above their target therapeutic range may be at risk for inappropriate therapeutic measures such as a warfarin dose reduction, interruption of warfarin use, or administration of vitamin K.

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  • Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients

    Thursday, December 27, 2018

    FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta.  These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death.  They can occur with fluoroquinolones for systemic use given by mouth or through an injection.

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  • Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

    Thursday, December 27, 2018

    Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

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  • Mylan Expands Its Voluntary Nationwide Recall

    Monday, December 10, 2018

    Mylan N.V. (NASDAQ: MYL) today (12/4/2018) announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochlorothiazide Tablets, USP (80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg strengths).

    Out of an abundance of caution, these products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Valsartan, USP, manufactured by Mylan Laboratories Limited. NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen according to the International Agency for Research on Cancer (IARC).

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