Sterility Issues with Avella's Injectables
Avella Specialty Pharmacy announced a voluntary recall of Bevacizumab 1.25mg/0.05mL PF and Vancomycin PF (BSS) 1%. This recall is a result of concerns of sterility assurance with the pharmacy's independent testing laboratory, Front Range Laboratories.
Bevacizumab is an angiogenesis inhibitor indicated for use in various cancers such as metastatic renal cell carcinoma, glioblastoma, colorectal carcinoma, and metastatic non-squamous, non-small cell lung cancer. Vancomycin is an antibiotic used for various bacterial infections and for C.difficile-associated diarrhea.
In a recent inspection, FDA investigators observed methods used to assess sterility, strength, and stability, which may have resulted in Avella receiving inaccurate laboratory test results on the affected lots.
If microbial contamination occurs in medications in sterile products, patients may be at risk for serious infections that may be life-threatening. These products were dispensed nationwide directly to healthcare providers. The specific lot numbers are as follows:
- Bevacizumab 1.25mg/0.05mL PF (Lot #12-20130508@179)
- Vancomycin PF (BSS) 1% (Lot #12-20130508@181)
Avella Specialty Pharmacy is notifying customers of the recall by phone and mail.
For more information call (877) 738-0797 or read the firm press release.