Infusion Options product 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 RITUXAN 728 MG QS 728 mL 0.9% NACL IVPB; RITUXAN 560 MG / 306 ml 0.9% NACL; RITUXAN 562 MG IN 562 ml 0.9% NACL; RITUXAN…

Recall number

D-1809-2019

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

RITUXAN 728 MG QS 728 mL 0.9% NACL IVPB; RITUXAN 560 MG / 306 ml 0.9% NACL; RITUXAN 562 MG IN 562 ml 0.9% NACL; RITUXAN 700 MG QS 700 mL 0.9% NACL IVPB; RITUXAN 1000 MG / 350 mL 0.9% NACL IVPB RITUXAN 730 MG / 730 mL 0.9% NACL IVPB; RITUXAN 1000 MG QS 1000 ml NS; RITUXAN 1000 MG QS 200 ml 0.9% NACL; RITUXAN 500 MG / 300 ml 0.9% NACL; RITUXAN 660 MG QS 660 ml 0.9% NACL; RITUXAN 770 MG QS 770 mL 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233