Recalls

LIFEPAK 15 Monitor/Defibrillator

Date of Recall: February 1, 2019

Recalling Firm(s): Stryker

Product: LIFEPAK 15 Monitor/Defibrillator

Scope of recall: Specific Units. You can find out of your unit is part of the recall by going to the website below and filling in your Account Number:

https://smartrecall.com/stryker/fa281lp15/

Description: Stryker has voluntarily recalled specific units of the LIFEPAK 15 Monitor/Defibrillator due to an issue that may cause the device to lock-up after a defibrillation shock is delivered. The lock-up condition is defined as a blank monitor display with LED lights on, indicating power to the device, but no response in the keypad and device functions. This has the potential to cause a delay delivery of therapy and this delay has the potential to cause serious injury or death.  Stryker has become aware of 58 complaints reported globally for this issue, including 6 events which the patient died following a delay in therapy. There are 13,003 devices potentially impacted by this issue and within the scope of this recall.

For more information, please see the safety announcement posted on the FDA website. https://www.fda.gov/Safety/Recalls/ucm630455.htm.

Losartan Potassium Tablets

Date of Recall: December 20, 2018

Recalling Firm(s): Torrent Pharmaceuticals Limited

Product: Losartan potassium tablets

Scope of recall: BO31C016 ( both 30 & 90 count bottles), 4DK3C005, 4DK3C004, 4DU3C040, 4DU3E049, 4DU3E050, 4L67C035, 4L67C035, 4L67C036, 4O50C005 and 4O49C013. See below.

Description: Torrent has voluntarily recalled ten lots of Losartan potassium tablets due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient manufactured by Indian pharmaceutical company Hetero Labs Limited. The impurity detected is N-nitrosodiethylamine (“NDEA”) — a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes. NDEA has been classified as a probable human carcinogen by the International Agency for Research on Cancer (“IARC”). Torrent reports that it has not received any reports of adverse events related to this recall.

Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. According to the FDA, patients who are on Losartan should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

For more information, please see the safety announcement posted on the FDA website. https://www.fda.gov/Safety/Recalls/ucm628966.htm.

Irbesartan and Irbesartan HCTZ Tablets

Date of Recall: January 18, 2019

Recalling Firm(s): Prinston Pharmaceutical Inc.

Product: Irbesartan and Irbesartan HCTZ Tablets.

Scope of recall: Please click on the link below to see specific recalled catalog numbers and associated lot numbers.

Description: Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., has voluntarily recalled one lot of Irbesartan and seven lots of Irbesartan HCTZ Tablets due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected is N-nitrosodiethylamine (“NDEA”) — a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes. NDEA has been classified as a probable human carcinogen by the International Agency for Research on Cancer (“IARC”). To date, Prinston Pharmaceutical, Inc. has not received any reports of adverse events related to this recall.

Ibesartan and Ibesartan HCTZ are used to control high blood pressure and for the treatment of heart failure. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to stopping and returning their medication. Patients are advised to continue taking their medication until they are given a new medication from their pharmacist or their doctor has prescribed a new medication and/or treatment plan.

For more information, please see the safety announcement posted on the FDA website. https://www.fda.gov/Safety/Recalls/ucm629627.htm.

CoaguChek Test Strips

Date of Recall: December 19, 2018

Recalling Firm(s): Terrific Care, LLC. / Medex Supply Dist, Inc.

Product: CoaguChek XS Test Strips

Scope of Recall: All catalog/reference numbers that do not end in 160. Affected Lot Numbers: 27216700 through 33449899

Description: Terrific Care and Medex Supply initiated a nationwide recall of Roche CoaguChek test strips which it distributed directly to U.S. consumers between December 27, 2017 and December 15, 2018 via courier service. These products have been found to inaccurately report high International Normalized Ratio (“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.

This recall is related to the recent Roche Diagnostics Recall. Roche Diagnostics, the manufacturer of CoaguChek meters and test strips, recently calibrated the CoaguChek XS PT Test Strips to provide INR test results that correspond to the most recent INR International Standard. Since this calibration, Roche Diagnostics has been informed of patients experiencing inaccurately high INR test results when testing with the affected.

For more information, please see the safety announcement posted on the FDA website. https://www.fda.gov/Safety/Recalls/ucm628976.htm.

Roche Diagnostics CoaguChek Test Strips

Date of Recall: October 31, 2018

Recalling Firm(s): Roche Diagnostics

Products:  CoaguChek XS Professional, CoaguChek XS Pro, CoaguChek XS Plus, CoaguChek XS PST and CoaguChek Vantus.

Scope of Recall: Please click on the link below to view a list of all recalled catalog numbers and associated lot numbers.

Description: Roche Diagnostics initiated a recall for CoaguChek XS PT test strips which it distributed directly to U.S. consumers. Roche Diagnostics, the manufacturer of CoaguChek meters and test strips, recently calibrated the CoaguChek XS PT Test Strips to provide INR test results that correspond to the most recent INR International Standard. Since this calibration, Roche Diagnostics has been informed of patients experiencing inaccurately high INR test results when testing with the affected. These products have been found to inaccurately report high International Normalized Ratio (“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.

For more information, please see the safety announcement posted on the FDA website. https://www.fda.gov/Safety/Recalls/ucm626140.htm

Robaxin 750mg Tablets

Date of Recall: September 28, 2018

Recalling Firm(s): Endo Pharmaceuticals

Products:  Robaxin 750mg Tablets, 100 Count Bottle pack.

Scope of Recall: Lot 216702P1 and Lot 220409P1. No other lots of Robaxin are affected by this recall.

Description: Endo Pharmaceuticals  initiated a recall for two lots of Robaxin (methocarbamol tabelts, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have the incorrect daily dosing on the label due to a labeling error. This labeling error misstates the daily dose as “two to four tablets four times daily” rather than the correct dosage of “two tablets three times daily.” Patients who follow the directions may experience significant drowsiness and/or dizziness, which may put them at risk of falls or an overdose which can result in seizures, coma, or possibly death. To date, Endo Pharmaceuticals has not received any reports of adverse reactions related to this recall.

For more information, please see the safety announcement posted on the FDA website. https://www.fda.gov/Safety/Recalls/ucm622008.htm

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