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 Wellness Pharmacy, Inc.
Following a recent inspection of Front Range Labs, where sterility and other quality control testing is performed for Wellness Pharmacy, FDA investigators expressed concern over laboratory methods that may have resulted in Wellness Pharmacy receiving inaccurate sterility test results on a number of products that were distributed to individual patients and to healthcare facilities nationwide. 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 Wellness Pharmacy products have been recalled:
- Dexpanthenol 250mg/mL
- Lot #: 130605@52
- Exp: 12/02/2013
- Magnesium Sulfate 50%
- Lot #: 130613@38
- Exp: 12/10/2013
- Methylcobalamin 1mg/mL
- Lot #: 130612@49
- Exp: 10/19/2013, 12/09/2013
- Sodium Phenylbutyrate 200mg/mL SDV PF
- Lot #: 130621@28
- Exp: 10/19/2013
- R.L. Glutathione 100mg/mL SUV PF
- Lot #: 130710@27
- Exp: 01/06/2014
- Ascorbic Acid (cassava) 500mg/mL
- Lot #: 130711@13
- Exp: 01/07/2014
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.
