On August 27, 2013, the FDA issued a trio of recall alerts regarding compounded drugs. In one of the safety alerts, the FDA announced the voluntary recall of certain sterile drug products from JCB Laboratories (JCB).
Following a recent inspection of Front Range Labs, where sterility and other quality control testing is performed for JCB, FDA investigators expressed concern over laboratory methods that may have resulted in JCB receiving inaccurate sterility test results on a number of products that were distributed to outpatient dialysis clinics in multiple states in July and August 2013. Inspections of the same testing facility, Front Range Labs, also prompted a recall of numerous compounded drugs from Wellness Pharmacy, Inc. The FDA explained that if medications intended to be sterile contain microbial contamination, patients are at risk of serious—potentially life-threatening—infections.
The following JCB products have been recalled:
- Sodium thiosulfate, 25% (250mg/mL)
- Lot #: 130701@9 – Exp: 12/28/2013
- Lot #: 130709@6 – Exp: 01/05/2014
- Lot #: 130717@2 – Exp: 01/13/2014
- Sodium citrate, 4% solution for injection (30mL multiple-dose vial)
- Lot #: 130710@4
- Exp: 01/06/2014
- Sodium citrate, 4% with gentamicin 320mcg/mL solution for injection (30mL multiple-dose vial)
- Lot #: 130620@2
- Exp: 12/17/2013
- Acetylcysteine, 20% solution for inhalation (4mL single-dose vial)
- Lot #: 130627@5
- Exp: 08/26/2013
If you or a loved one has been affected by a compounding pharmacy product, contact us at www.andrewsthornton.com or toll free at 1-800-644-1734.