FDA MedWatch

Windstone Medical Packaging dba Aligned Medical Solutions Issues Nationwide Recall of Cardinal Health’s Monoject™ Flush Prefilled Saline Syringes Placed Into the Following Kits; AMS-9041CP Leaderflex Insertion Kit With Ultrasound, AMS-9046CP-1...

Aligned Medical Solutions initiated a nationwide recall of Cardinal Health’s Monoject™ Flush Prefilled Saline Syringes placed into 9,378 kits. These convenience kits have been found to contain the Cardinal Health’s Monoject™ Flush Prefilled Saline Syringe part # 8881570121, which has been recalled f

Merck Issues Voluntary Nationwide Recall of CUBICIN® (Daptomycin for Injection) 500 mg, Lot 934778, Due to Presence of Particulate Matter Identified as Glass Particles

Merck (NYSE: MRK), known as MSD outside the United States and Canada, is voluntarily recalling one lot of CUBICIN® (daptomycin for injection) 500mg for intravenous use, Lot 934778, Exp June 2022. Because treatment with CUBICIN is likely to be initiated at a hospital or other monitored healthcare se

Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of All Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets Due to Potential Presence of N-nitrosoirbesartan Impurity

Baltimore, Maryland, October 14, 2021: Lupin Pharmaceuticals Inc. is voluntarily recalling the below-mentioned batches of Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets to the consumer level. As part of Lupin’s ongoing assessment, analysis revealed that certain tested API batches

2021 Safety Communications

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.

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