SPS-1 Static Preservation Solution distributed by Organ Recovery Systems: Safety Communication

[Posted 03/09/2017] AUDIENCE: Surgery, Infectious Disease, Transplantation, Risk Manager ISSUE: On Dec. 14, 2016, staff at a health care facility notified the FDA of an uncharacteristic odor from SPS-1 encountered during an organ procurement operation. Laboratory results from fluid samples and cultures from the SPS-1 used for this operation confirmed contamination with Pantoea and Enterococcus…

Balloon angioplasty devices to treat autonomic dysfunction: FDA Safety Communication

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Dietary Supplements for Male Sexual Enhancement by A and H Focal: Recall

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Edex (alprostadil for injection) 10 mcg 2 Pack by Endo Pharmaceuticals: Recall

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Avella Specialty Pharmacy Unexpired Sterile Injectable Products Labeled “Latex Free”: Recall

[Posted 02/24/2017] AUDIENCE: Pharmacy, Risk Manager ISSUE: Advanced Pharma, Inc. d/b/a Avella of Houston, is conducting a voluntary recall of all unexpired sterile injectable products labeled “latex free” that were produced at Advanced Pharma, Inc.’s Houston location between September 1, 2016 and February 16, 2017 to the user level (hospitals and institutions) because such products…

XtraHRD Natural Male Enhancement Capsules by Organic Herbal Supply, Inc.: Recall

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Comprehensive Reverse Shoulder by Zimmer Biomet: Class I Recall

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HCG (Human Chorionic Gonadotropin) Freeze Dried Vials by Synergy Rx: Recall

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Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL) by Exela Pharma Sciences: Recall

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