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FDA Medwatch News Feed

Viona Pharmaceuticals Inc., Issues Voluntary Nationwide Recall of Metformin HCl Extended-Release Tablets, USP 750 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity | Fri, 11 Jun 2021 00:00:00 EDT

Viona Pharmaceuticals Inc., is voluntarily recalling 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg to the retail level.

2021 Safety Communications | Thu, 10 Jun 2021 08:31:00 EDT

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.

Stop Using Innova SARS-CoV-2 Antigen Rapid Qualitative Test: FDA Safety Communication | Thu, 10 Jun 2021 00:00:00 EDT

The FDA has significant concerns that performance of the test has not been adequately established, presenting a risk to health.

Innova Medical Group Recalls Unauthorized SARS-CoV-2 Antigen Rapid Qualitative Test with Risk of False Test Results | Thu, 10 Jun 2021 00:00:00 EDT

Innova SARS-CoV-2 Antigen Rapid Qualitative Test performance characteristics have not been adequately established, presenting a risk of false results.

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