FDA Drug Recalls

Recalls / Class II

Class IID-1308-2019

Product

Bevacizumab 2.5 mg/0.1 mL, packaged in a Prefilled Syringe, Rx only, AVELLA SPECIALTY PHARMACY 24416 N. 19TH AVENUE PHOENIX, AZ 85085, NDC 42852-001-27

Affected lot / code info
Lot #: 138-20191202@64, Exp 05/13/19

Why it was recalled

Lack of assurance of sterility

Recalling firm

Firm
Avella of Deer Valley, Inc. Store 38
Notification channel
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Type
Voluntary: Firm initiated
Address
24416 N 19th Ave, N/A, Phoenix, Arizona 85085-1887

Distribution

Quantity
730 syringes
Distribution pattern
U.S.A. nationwide

Timeline

Recall initiated
2019-05-03
FDA classified
2019-05-29
Posted by FDA
2019-06-05
Terminated
2020-02-25
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1308-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.