FDA Drug Recalls

Recalls / Class II

Class IID-0224-2019

Product

BEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in normject syringe) Repackaged by Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix, AZ 85085. NDC 42852-001-24

Affected lot / code info
Lot # 138-20182408@58 BUD 12/22/2018

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm
Avella of Deer Valley, Inc. Store 38
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
24416 N 19th Ave, Phoenix, Arizona 85085-1887

Distribution

Quantity
911 syringes
Distribution pattern
Product was distributed throughout the United States.

Timeline

Recall initiated
2018-10-31
FDA classified
2018-11-07
Posted by FDA
2018-11-14
Terminated
2019-01-18
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0224-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls