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Sandoz, Inc. Issues Nationwide Recall of 13 Lots of Orphenadrine Citrate 100 mg Extended Release Tablets Due to Presence of a Nitrosamine Impurity

Murilo Freitas - 04:00, 21 de marzo de 2022405

Sandoz Inc. (“Sandoz”) is initiating a voluntary recall of 13 lots (listed below) of oral Orphenadrine Citrate 100 mg Extended Release (ER) Tablets to the consumer level.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-nationwide-recall-13-lots-orphenadrine-citrate-100-mg-extended-release-tablets-due

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Philips Respironics Recalls Certain V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm

Murilo Freitas - 04:00, 20 de marzo de 2022418

Certain Philips Respironics V60 and V60 Plus ventilators recalled due to expired adhesive that may cause ventilator to stop delivering ventilation with or without an alarm.

http://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-v60-and-v60-plus-ventilators-expired-adhesive-may-cause

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Prefilled Saline Flush Syringe Conservation Strategies – Letter to Health Care Personnel

Murilo Freitas - 04:00, 20 de marzo de 2022372

The FDA recommends conservation strategies to minimize the use of these prefilled saline flush syringes and maintain the quality and safety of care for patients.

http://www.fda.gov/medical-devices/letters-health-care-providers/prefilled-saline-flush-syringe-conservation-strategies-letter-health-care-personnel

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Use and Store At-Home COVID-19 Tests Properly to Avoid Potential Harm: FDA Safety Communication

Murilo Freitas - 04:00, 17 de marzo de 2022364

These tests can be dangerous if the parts of the test kit are swallowed or if the liquid solutions touch a person’s skin or eyes.

http://www.fda.gov/medical-devices/safety-communications/use-and-store-home-covid-19-tests-properly-avoid-potential-harm-fda-safety-communication

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Celltrion USA Recalls Certain Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results and Unauthorized Shelf Life

Murilo Freitas - 04:00, 16 de marzo de 2022327

Certain lots of Celltrion USA’s DiaTrust COVID-19 Ag Rapid Tests are being recalled for a high number of false positives and a longer shelf life than authorized by the FDA

http://www.fda.gov/medical-devices/medical-device-recalls/celltrion-usa-recalls-certain-celltrion-diatrust-covid-19-ag-rapid-tests-false-positive-test-results

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Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests: FDA Safety Communication

Murilo Freitas - 04:00, 15 de marzo de 2022437

These tests have not been authorized, cleared, or approved. The FDA is concerned about the risk of false results when using these tests.

http://www.fda.gov/medical-devices/safety-communications/do-not-use-sd-biosensor-standard-q-covid-19-ag-home-tests-fda-safety-communication

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SD Biosensor Recalls STANDARD Q COVID-19 Ag Home Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results

Murilo Freitas - 04:00, 15 de marzo de 2022327

SD Biosensor’s STANDARD Q COVID-19 Ag Home Tests are being recalled because they are not authorized, cleared, or approved by the FDA and may give false results.

http://www.fda.gov/medical-devices/medical-device-recalls/sd-biosensor-recalls-standard-q-covid-19-ag-home-tests-are-not-authorized-cleared-or-approved-fda

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