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Recall Observatory FDA recall evidence

Drug 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

D-1761-2019

June 12, 2019

Class II

Product summary

Firm
Infusion Options, Inc.
Event
Event 83136
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-1761-2019

Official wording

Reason: Lack of Assurance of Sterility

Code information: All lots within expiry

Distribution pattern: NY only

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility