D-1059-2013 Class II Terminated
FDA drug recall D-1059-2013 was initiated by Avella of Deer Valley, Inc. on September 9, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory. The recall status is terminated (terminated October 17, 2013). Affected quantity: 250 units.
Recall Details
- Product Type
- Drugs
- Report Date
- September 25, 2013
- Initiation Date
- September 9, 2013
- Termination Date
- October 17, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 250 units
Product Description
Vancomycin PF (BSS) 1%, 1 mL, Avella Specialty Pharmacy, Phoenix, AZ 85085, 877-782-7684
Reason for Recall
Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
12-20130508@181, Exp 10/4/2013