Possible Yeast on Pharmaceutical Supplies Causes Recall
EMSL Analytcal provides pharmaceutical supply analyses through cBMP bioburden and sterility testing.
The U.S. Food and Drug Administration (FDA) has reported a voluntary recall of two lots of Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use because they may contain a strain of yeast on one of more parts. The two affected lots are considered non-sterile and unsafe for use.
The Mitosol Kits are an antimetabolite used by physicians in hospitals and clinics during ab externo glaucoma surgery. The use of contaminated products could cause serious eye injuries or infections, including the possibility of blindness.
The affected products have lot numbers of M098260 and M086920, and both have expiration dates of 8/2013. These lots were distributed between October 22, 2012 and December 14, 2012 to the following states: Alabama, Arkansas, Delaware, Georgia, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Virginia, and Wisconsin.
Mitosol has contacted all affected customers, and to date there have been no reports of injury related this recall.
“According to the FDA, an investigation has begun to determine the cause of the yeast, and corrective and preventative actions,” states Diane Miskowski, MPH, Business Development Manager at EMSL Analytical, Inc. “EMSL Analytical, the nation’s leading environmental testing laboratory, has FDA registered, DEA licensed, cGMP compliant laboratories located throughout the United States that provide advanced testing on pharmaceutical samples through our cGMP bioburden and sterility testing.
About EMSL Analytical, Inc.
EMSL Analytical is a full service testing company providing quality lab services under the same private ownership since 1981. Including the corporate lab facility in Cinnaminson, NJ, EMSL Analytical operates over thirty laboratories nationwide in the US and Canada. We provide analytical services for environmental, indoor air quality (IAQ), industrial hygiene, forensics and materials science, consumer products, food safety, PCR, pharmaceutical, asbestos, lead, and radiological samples. The company has an extensive list of accreditations from leading organizations, as well as state and federal regulating bodies.
- Contact Information
- Joseph Frasca
- Senior Vice President of Marketing
- EMSL Analytical
- (1) 1-800-220-3675
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