1. Citing a lack of sterility assurance, Abrams Royal Pharmacy in Dallas issued a voluntary recall on all lots of unexpired sterile products.
2. Chesire, Conn.-based Alexion Pharmaceuticals updated its voluntary recall, requesting hospitals return any unused vials of Soliris Concentrated Solution for Intravenous Infusion due to visible particles in the solution that could cause immunogenicity and thromboembolic risk.
3. The U.S. Food and Drug Administration issued a Class I Recall on Spacelabs Healthcare’s BleaseSirius and BleaseFocus Anesthesia Workstations. Loose hardware in the CAS I/II Absorbers could cause the Bag-to-Vent switch to fail.
4. Pomona, Calif.-based CLR Medicals International issued a nationwide recall on its Viscocel and Viscocel Plus products because they are being marketed without FDA approval.
More Articles on the FDA:
FDA, European Medicines Agency to Collaborate on Generic Drug Approvals
FDA, CMS Extend Parallel Review Program
FDA Names GS1 First Accredited Issuing Agency for UDIs
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