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Hospira Recalls Antibiotic for Presence of Glass Particles

by Devices and Pharma | Dec 31, 2022 | Alerts, Alerts-Pharma, Class I Recalls, Consumer Safety, Industry News, Pharmaceuticals, Product Recalls, Product Safety, US-FDA

Hospira Recalls Antibiotic for Presence of Glass Particles Product was distributed throughout the U.S. and Puerto Rico Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation...

Three Companies Recall Blood Pressure Medication

by Devices and Pharma | Dec 30, 2022 | Alerts, Alerts-Pharma, Consumer Information, Consumer Safety, Industry News, Pharmaceuticals, Product Recalls, Product Safety, US-FDA

Three Companies Recall Blood Pressure Medication Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact All recalled products had unacceptable levels of nitrosamines Three...

FDA Announces Online Electronic 510(k) Submissions

by Devices and Pharma | Dec 18, 2022 | Med-Devices, Reg_Information, US-FDA

The U.S. Food and Drug Administration (FDA) announced the issuance of its final guidance document for its template for electronic 510(k) submissions on September 22, 2022. The electronic Submission Template and Resource (eSTAR) electronic submissions template is a...
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