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JCB Laboratories Products: Recall - Sterility Assurance at Testing Vendor

Friday, August 30, 2013

AUDIENCE: Health Professional, Risk Manager

ISSUE: JCB Laboratories (JCB) is issuing a recall of six lots of sterile drug products to the user level due to concerns of sterility assurance following a recent inspection by FDA of Front Range Laboratories of Loveland, Colorado, one of the contract testing labs used by JCB. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.

BACKGROUND: The following JCB Laboratories compounded products are subject to the recall: Sodium thiosulfate, 25% (250 mg/mL), Sodium citrate, 4% solution for injection, Sodium citrate, 4% with gentamicin 320 mcg/mL solution for injection, and Acetylcysteine, 20% solution for inhalation (see firm press release for lot numbers). The recalled products were distributed to outpatient dialysis clinics in multiple states from July 8, 2013, through Aug. 20, 2013. JCB has not received any reports of adverse events related to this recall to date.  In the recent inspection of Front Range Labs, the FDA stated it observed that methods used by Front Range to assess sterility and other qualities (e.g., strength and stability) may have resulted in pharmacies receiving inaccurate laboratory test results.

RECOMMENDATION: Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product. JCB has begun notifying its customers by telephone, email, fax and mail. To return product or request assistance related to this recall, users should contact JCB Laboratories at 316-773-0405, Monday through Friday, between 8:00 a.m. and 5:00 p.m. CDT.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: 

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the complete MedWatch Safety Alert, including a link to the firm press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm366503.htm

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