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December 18, 2014

0.9 Percent Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container by Baxter: Recall - Particulate Matter


FDA MedWatch Recall - Particulate Matter

November 21, 2014

FDA MedWatch - Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur


FDA MedWatch Respironics California Esprit V1000 and V200 Ventilators Class I Recall

November 21, 2014

FDA MedWatch - Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall - Mislabeled


Highly Concentrated Potassium Chloride Injection 10 mEq per 100 mL by Baxter Recall Mislabeled



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Generic Drug Industry Proposal to Address Drug Shortages Gets FTC Approval

Friday, August 10, 2012

The Generic Pharmaceutical Association (GPhA) received a Federal Trade Commission (FTC) Advisory Opinion permitting a plan to address drug shortages to move forward.  The GPhA’s plan is titled the "Accelerated Recovery Initiative (ARI)," and it would operate by generic drug manufacturers communicating production details of critical drugs to health care technology company, IMS Health.  This information would be pooled together with other IMS Health market data and then shared with the Food and Drug Administration.  Reportedly, with this information, the FDA would have a comprehensive real time view of drug production in the generic market place and could work more quickly and efficiently to avert shortages.

The announcement of the FTC's Advisory Opinion citing no antitrust violations with this ARI plan comes in the wake of the recently passed "Food and Drug Administration Safety Act," which placed a high value on enhanced notification of drug shortages. 

More about drug shortages.

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