News By Tag
News By Place
Fungal Contamination of Pharmaceutical Products Leads to 33 Eye Infections
EMSL Analytical’s FDA registered, cGMP and ISO 17025 compliant lab offers sterility and chemical testing
All patients with the infections had undergone either eye surgeries or injections. According to the Centers for Disease Control and Prevention (CDC), 23 of them experienced some type of vision loss, and 24 patients needed another eye surgery.
The Food and Drug Administration (FDA) tested unopened bottles and unused syringes of the products at Franck’s Compounding Lab and discovered numerous bacterial and fungal species.
Franck’s issued a recall of one lot of triamcinolone acetonide P.F. 80mg/ml; however, CDC officials say that the investigation is still on-going and warn doctors and patients to avoid any of Franck’s compounding products labeled as sterile.
Health officials found fault with Franck’s business in 2009 after 21 polo horses died before a championship match in West Palm Beach. On the orders of the team’s veterinarian, they had been given vitamins and minerals by the pharmacy, which accidentally put a fatal dose of selenium into the cocktail.
“EMSL Analytical’s FDA registered, cGMP and ISO 17025 compliant lab offers sterility and chemical testing for pharmaceuticals, biopharmaceauticals, medical devices, biotechnology, and personal care products,” states EMSL’s Business Development Manager, Diane Miskowski, MPH. “Our pharmaceutical testing team includes experts with advanced degrees in mycology, bacteriology, molecular biology, and chemistry, among other disciplines.”
For more information on EMSL Analytical, please contact us at (800) 220-3675 or visit www.EMSL.com.
About EMSL Analytical, Inc.
EMSL Analytical is a nationally recognized and locally focused provider of consumer product, environmental, industrial hygiene, food, and materials testing services to professionals and the general public. In addition, the company offers a large variety of air sampling equipment, sampling cassettes, and monitoring equipment. The company has an extensive list of accreditations from leading organizations, as well as state and federal regulating bodies. They include, but are not limited to AIHA IHLAP, AIHA EMLAP, AIHA ELLAP, A2LA, NVLAP, CDC Elite, CPSC (Consumer Product Safety Commission), CA ELAP, NY ELAP, TX Department of State Health Services, and multiple other state accrediting agencies. Please visit our website for a complete listing of accreditations.