FDA recall D-1059-2013

Avella of Deer Valley, Inc. · Class II · drug

Product

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

Nationwide and Puerto Rico

Key facts

Status
Terminated
Initiation date
2013-09-09
Report date
2013-09-25
Termination date
2013-10-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Phoenix, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1059-2013