Cyclophosphamide 840 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 Cyclophosphamide 840 MG / 250 ML NS IVPB; Cyclophosphamide 1112 MG / 250 ML NS IVPB; Cyclophosphamide 1248 MG / 50 ML N…

Recall number

D-1761-2019

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

Cyclophosphamide 840 MG / 250 ML NS IVPB; Cyclophosphamide 1112 MG / 250 ML NS IVPB; Cyclophosphamide 1248 MG / 50 ML NS IVPB; Cyclophosphamide 1125 MG / 100 ML NS IVPB; Cyclophosphamide 1000 MG / 500 ML NS IVPB; Cyclophosphamide 1400 MG / 100 ML NS IVPB Cyclophosphamide 1056 MG / 250 ML NS IVPB; Cyclophosphamide 980 MG / 500 ML NS IVPB; Cyclophosphamide 580 mg / 500 ML NS IVPB; Cyclophosphamide 880 MG / 500 ML NS IVPB; Cyclophosphamide 501 MG / 250 ML NS IVPB; Cyclophosphamide 1163 MG / 50 ML NS IVPB Cyclophosphamide 1100 MG / 500 ML NS IVPB; Cyclophosphamide 1152 MG / 250 ML NS IVPB; Cyclophosphamide 1116 MG / 250 ML NS IVPB Cyclophosphamide 894 MG / 250 ML NS IVPB; Cyclophosphamide 1210 MG / 500 ML NS IVPB; Cyclophosphamide 1010 MG/ 500 ML NS IVPB Cyclophosphamide 1030 MG / 500 ML NS IVPB; Cyclophosphamide 500 MG / 250 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233