Month: October 2017

SCA Pharmaceuticals Issues Voluntary Nationwide Recall of Specific Products Due to Potential Contamination

SCA Pharmaceuticals LLC (“SCA Pharmaceuticals”) is voluntarily recalling all/the following lots of the below listed injectable products to the hospital level. The is a potential for the products to contain microbial contamination. Administration of a drug product, intended to be sterile, that may contain microbial contamination has the potential to result in serious adverse events …

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Nurse practitioner indicted in compound pharmacy scheme

  A nurse practitioner was indicted Oct. 18 for her alleged role in a compound pharmacy scheme with roots in Hattiesburg. Susan Perry of Grand Bay, Alabama, who operated Immediate Family Clinic in Biloxi, was arraigned Wednesday in Gulfport before U.S. District Court Mississippi Southern District Magistrate John Gargiulo. She was released on a $25,000 unsecured …

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Aseptic Enclosures BootieMatic XL

The BootieMatic XL is an automatic clean room Bootie dispenser. Holds approximately 200 booties. Many booting types available.   Features More aseptic More than 5X faster. Significant cost savings. Reduced risk of injury. Reduced insurance costs. More space efficient. More aseptic. More comfortable   Need more information on this product? Give us a call at 1.800.418.9289

Pharmacist In Meningitis Case Gambled With Lives, Prosecutor Says

  A pharmacist charged with murder in a meningitis outbreak that killed 76 people knew that mold and other bacteria were growing inside the filthy production rooms and that drugs shipped to customers were not sterile, but chose to do nothing, a federal prosecutor told jurors Friday. Glenn Chin, the supervisory pharmacist at the now-closed …

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FDA: Compounded Ocular Antibiotic May Cause Blindness

Compounded triamcinolone-moxifloxacin-vancomycin (TMV), a medication used for intraocular injection, may cause a rare, potentially blinding postoperative complication, according to the FDA.   The agency has issued a Compounding Risk Alert concerning a report of hemorrhagic occlusive retinal vasculitis (HORV) that occurred in a patient being treated with TMV after cataract surgery. HORV may include delayed onset …

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Compounded bioidentical hormone therapy: Does the regulatory double standard harm women?

While use of menopausal hormone therapy products has trended downward in recent years, evidence suggests U.S. women increasingly are turning to compounded bioidentical hormone therapy (cBHT) to combat hot flashes and other symptoms. While use of menopausal hormone therapy products has trended downward in recent years, evidence suggests U.S. women increasingly are turning to compounded …

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FDA Provides Guidance for Compounders

The FDA understands the importance of access to compounded drugs, and is committed to supporting access to these drugs under “high production standards,” according to a recently-released statement from FDA Commissioner Scott Gottlieb, MD. The Drug Quality and Security Act (DQSA) provides a pivotal foundation for achieving these goals, by working with outsourcing facilities to …

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