JCB Laboratories Issues Voluntary Recall of Six Drug Product Lots Due to Concerns of Sterility Assurance at Testing Vendor

Date of Recall

2013-08-27

Recall Details

- August 26, 2013 - WICHITA, Kan. - 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 the U.S. Food and Drug Administration of Front Range Laboratories of Loveland, Colo., one of the contract testing labs used by JCB.

The following compounded products are subject to the recall:

• Sodium thiosulfate, 25% (250 mg/mL) - Lot numbers 130701@9 (Exp. 12/28/13), 130709@6 (Exp. 1/5/14) and 130717@2 (Exp. 1/13/14)
• Sodium citrate, 4% solution for injection, 30 mL multiple dose vial - Lot number 130710@4 (Exp. 1/6/14)
• Sodium citrate, 4% with gentamicin 320 mcg/mL solution for injection, 30 mL multiple dose vial - Lot number 130620@2 (Exp. 12/17/13)
• Acetylcysteine, 20% solution for inhalation, 4 mL single dose vials - Lot number 130627@5 (Exp. 8/26/13)

JCB has not received any reports of adverse events related to this recall to date. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.

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

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. FDA has concerns that results obtained from Front Range are not reliable. FDA recommends that pharmacies not use this firm for sterility and other quality attributes testing at this time."
(http://www.fda.gov/Drugs/DrugSafety/ucm365920.htm, 8/21/13)

Out of an abundance of caution, JCB has discontinued its relationship with Front Range and is now testing products at a different laboratory.

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