Recall: Six Drug Products from JCB Labs

JCB Laboratories has issued a recall of six lots of sterile drug products. During the FDA’s recent inspection of Front Range Labs for sterility and other qualities, the FDA was concerned about inaccurate and unreliable lab test results for sterility assurance.

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The following compounded products are being recalled:

• Sodium thiosulfate, 25% (250 mg/mL) – Lot numbers [email protected] (Exp. 12/28/13), [email protected] (Exp. 1/5/14) and [email protected] (Exp. 1/13/14)
• Sodium citrate, 4% solution for injection, 30 mL multiple dose vial – Lot number [email protected] (Exp. 1/6/14)
• Sodium citrate, 4% with gentamicin 320 mcg/mL solution for injection, 30 mL multiple dose vial – Lot number [email protected] (Exp. 12/17/13)
• Acetylcysteine, 20% solution for inhalation, 4 mL single dose vials – Lot number [email protected] (Exp. 8/26/13)

The recalled products were distributed to outpatient dialysis clinics in multiple states from July 8, 2013 through August 20, 2013.

JCB is notifying its customers and is arranging for the return of all recalled product lots.

For more information call (316) 773-0405 or visit FDA.gov.