Sterile Compound Products Recalled Due to Possible Contamination
EMSL Analytical provides particulate, sterility and USP Monograph testing in our FDA registered and DEA licensed laboratory.
According to the U.S. Food and Drug Administration (FDA), Pallimed Pharmacy of Woburn, MA has issued a voluntary recall of all sterile compound products after the Massachusetts Board of Registration detected visible particulates in five vials.
As a precautionary measure, Palimed Pharmacy has included all products distributed between January 1, 2013 and March 22, 2013 in this recall. Affected products are packaged in glass vials and have been distributed to patients and physicians’ offices across the U.S.
Products included in this recall are used for therapeutic purposes, including erectile dysfunction treatment, testosterone replacement therapy, vitamin injections, and ophthalmic preparations.
The particulate matter involved in this recall has not yet been identified, therefore risk factors are unknown. However, particulate matter has the ability to damage or block blood vessels, causing blood clots, allergic reactions, and tissue responses.
To date, no illnesses or infections have been reported in association with this recall.
“It is important that compounding pharmacies frequently perform Sterility and USP Monographs on their products and active pharmaceutical ingredients in order to protect consumers from potentially dangerous contaminations,” states Diane Miskowski, MPH, Business Development Manager at EMSL Analytical, Inc. “To assist compounding pharmacies in complying with USP 797 standards, EMSL Analytical, the nation’s leading environmental testing laboratory, provides sterility testing for controlled substances in our FDA registered, DEA licensed laboratories.”
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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