September 9, 2013 — The U.S. Food and Drug Administration (FDA) and Avella Specialty Pharmacy have issued a compounding pharmacy recall for two medications because of a lack of sterility assurance. No injuries have been reported, and the recall is being issued “out of an abundance of caution.”
The recalled medications include Avastin (bevacizumab), which is a cancer drug that is often compounded into smaller doses for the treatment of macular degeneration. The other medication is vancomycin, which is an antibiotic used to treat gastrointestinal infections.
The recall was initiated after the FDA found problems during an inspection of Front Range Laboratories, which is an independent lab that does sterility testing for Avella Specialty Pharmacy. Avella has discontinued its relationship with the laboratory.
The FDA warned:
“FDA investigators observed methods used to assess sterility and other qualities (e.g. strength and stability) which may have resulted in Avella receiving inaccurate laboratory test results on the specified lots. … Test results obtained from Front Range Labs may not be reliable.”
| Product | Lot Number | Expiry |
|---|---|---|
| Bevacizumab 1.25 mg/0.05 mL PF | 12-20130508@179 | 11/3/2013 |
| Vancomycin PF (BSS) 1% | 12-20130508@181 | 10/4/2013 |
The FDA’s regulatory actions on compounding pharmacies have increased substantially in 2013, with more inspections, warning letters, and recalls than ever before. The added enforcement is a result of a massive outbreak of fungal meningitis last year that killed 63 people and injured at least 750.
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