Recalls / Class II

Class IID-1761-2019

Product

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

Affected lot / code info

All lots within expiry

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm

Infusion Options, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

5924 13th Ave, N/A, Brooklyn, New York 11219-4934

Distribution

Quantity

N/A

Distribution pattern

NY only

Timeline

Recall initiated

2019-06-12

FDA classified

2019-08-15

Posted by FDA

2019-08-21

Terminated

2025-03-21

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1761-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.