Sterile Prescriptions Recalled after FDA Finds Company’s Clean Room Contaminated
EMSL Analytical provides sterility testing in our cGMP, ISO 17025 laboratory.
The Food and Drug Administration (FDA) detected the presence of microorganisms in the clean room of Franck’s Compounding Lab, which has initiated a recall of all sterile human and veterinary prescription products that it distributed.
The recall applies to all sterile preparations from the Florida-based company since November 21, 2011.
The compounding laboratory has faced issues with the sterility and chemical composition of their products in the past.
Earlier this year, health officials reported that tainted preparations caused 33 rare fungal eye infections in patients who had undergone eye surgery. While investigating, the FDA discovered numerous fungal and bacterial species in unopened products at the compounding pharmacy.
In 2009, the authorities faulted Franck’s 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.
The company states in a press release that the recall should be carried out at the physician level and asks that doctors review patient records to determine if any adverse events possibly resulted from use of the contaminated products. Any problems associated with the use of Frank’s prescriptions should be reported to the company and the FDA’s MedWatch program.
“EMSL Analytical’s FDA registered lab offers cGMP and ISO 17025 compliant 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. 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.
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- Joseph Frasca
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- EMSL Analytical, Inc.
- (1) 1-800-220-3675
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