Bedford Laboratories Issues Recall on Leucovorin Calcium Injection Product
EMSL Analytical offers FDA-registered lab offers cGMP and ISO 17025 compliant materials testing for pharmaceuticals.
After discovering visible crystalline particulate matter in a small number of vials, Bedford Laboratories has issued a nationwide recall of Leucovorin Calcium Injection. The particles have been identified as an active drug substrate and are not a due to any foreign contamination.
While no adverse reactions have been reported, the particulate matter presents a potential health hazard. The lots recalled have shipping dates from January to June 2011.
According to the U.S. Department of Health and Human Services, adverse reactions resulting from the injection of a contaminated dose could include vein irritation and phlebitis, clinically occult pulmonary granulomas, local tissue infarction, severe pulmonary dysfunction, or even anaphylactic shock and death.
“EMSL Analytical’s FDA registered lab offers cGMP and ISO 17025 compliant materials testing for pharmaceuticals, biopharmaceuticals, 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.”
About EMSL Analytical, Inc.
EMSL Analytical, Inc. 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 VP of Marketing
- EMSL Analytical, Inc.
- (1) 1-800-220-3675
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