BEVACIZUMAB 784 MG / NS IVPB recalled over sterility concerns

Recall date

June 12, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Infusion Options, Inc. recalls BEVACIZUMAB 784 MG / 100 ML NS IVPB; BEVACIZUMAB 350 MG/100 ml NS IVPB; BEVACIZUMAB 425 MG/ 100 ml NS IVPB; BEVACIZUMAB…

Recall number

D-1752-2019

FDA classification

Class II

Brand / firm

Infusion Options, Inc.

Sold / distributed

NY only

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BEVACIZUMAB 784 MG / 100 ML NS IVPB; BEVACIZUMAB 350 MG/100 ml NS IVPB; BEVACIZUMAB 425 MG/ 100 ml NS IVPB; BEVACIZUMAB 420 MG/100 ml 0.9% NACL IVPB; BEVACIZUMAB 556 mg/100 ml NS IVPB BEVACIZUMAB 330 MG / 100 ML NS IVPB; BEVACIZUMAB 790 MG / 100 ML NS IVPB; BEVACIZUMAB 470 MG / 100 ML NS IVPB; BEVACIZUMAB 758 MG / 100 ML NS IVPB; BEVACIZUMAB 690 MG / 100 ML NS IVPB BEVACIZUMAB 599 MG/100 ml NS IVPB; BEVACIZUMAB 1113 MG / 100 ML NS IVPB; BEVACIZUMAB 660 MG /100 ml NS IVPB; BEVACIZUMAB 590 MG / 100 ML NS IVPB; BEVACIZUMAB 620 MG / 100 ML NS IVPB BEVACIZUMAB 800 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233