Compounding Pharmacy Issue Recall after Fifteen Patients Develop Infections

According to USA Today, the U.S. Food and Drug Administration, FDA, has issued a voluntary recall of all sterile products manufactured at a compounding pharmacy in Texas.

Fifteen patients at two hospitals have developed bacterial bloodstream infections after receiving calcium gluconate injections supplied by Specialty Compounding from Cedar Park, TX. The bacterial bloodstream infections were found to be caused by the organism, Rhodococcus equi.

Since last year’s fungal meningitis outbreak, which killed 63 and sickened 749, compounding pharmacies have been under increased scrutiny. Compounding pharmacies are licensed to prepare customized drugs for individuals based on doctor’s prescriptions. However, many pharmacies have begun supplying hospitals and clinics with bulk quantities of drugs without prescriptions.

A Senate committee approved a bill in May that established a uniform, national prescription drug-tracing structure to protect the nation’s drug supply chain. The bill will clarify state and federal oversight and regulation of compounding pharmacies.

“It is crucial to patient’s health for compounding pharmacies to comply with USP 797 standards and perform Sterility and USP Monograph on their products and active pharmaceutical ingredients periodically,” states Diane Miskowski, MPH, Business Development Manager at EMSL Analytical, Inc. “EMSL Analytical, the nation’s leading environmental testing laboratory, operate an FDA registered, DEA licensed, and ISO 17025 compliant laboratory to assist compounding pharmacies in complying with USP 797 standards.”

For more information about EMSL’s testing services, please contact EMSL at 800-220-3675, email  info@EMSL.com , or visit http://pharmaceuticaltestinglaboratory.com.

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

jfrasca@emsl.com