Cytarabine 128 MG/ D5W 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 Cytarabine 128 MG/250 ML D5W IVPB; Cytarabine 20 MG / 1 ML SQ SYRINGE Cytarabine 70 MG QS 6 ML PF NS SYRINGE; Cytarabin…

Recall number

D-1762-2019

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

Cytarabine 128 MG/250 ML D5W IVPB; Cytarabine 20 MG / 1 ML SQ SYRINGE Cytarabine 70 MG QS 6 ML PF NS SYRINGE; Cytarabine 100 MG QS 3 ML PF NS SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233