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.
The following compounded products are being recalled:
- 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)
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.