Recall Notices

Exactech Recall

Medical device company, Exactech, Inc., has issued recalls involving certain components used in its knee, hip, and ankle replacement systems due to an increased risk of premature failure.

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Irbesartan and Irbesartan HCTZ Tablets

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.

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Losartan Potassium Tablets

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.

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Philips Respironics – CPAP Recall

On June 14, 2021, Philips Respironics issued a recall notification because of potential health risks associated with the polyester-based polyurethane (PE-PUR) sound reduction foam used in specific Philips Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, as well as certain mechanical ventilators. Philips acknowledged that the PE-PUR foam may degrade or fall apart into tiny black particles that can enter the device’s humidifier, tubing and mask and be ingested or inhaled by the user. Testing by Philips also found that the foam can produce unsafe chemical levels that are released as gases.

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Valsartan Recall Lawsuit

Multiple manufacturers have voluntarily recalled their Valsartan medication after the FDA issued its largest ever class 1 recall due to N-Nitrosodimethylamine (NDMA) in supplies that were produced by Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP). NDMA Is a known human carcinogen that can lead to serious health risks in high doses and through prolonged exposure. The FDA first initiated a recall of Valsartan, both on its own and in combination with other pharmaceuticals, in July 2018 and have since expanded the recall to include additional manufacturers as of January 2019.

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