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Recall Observatory FDA recall evidence

Drug product

OXALIPLATIN 145 MG /250 ML D5W IVPB; OXALIPLATIN 154 MG / 250 ML D5W IVPB; OXALIPLATIN 130 MG / 250 ML D5W IVPB; OXALIPLATIN 140 MG / 250 ml D5W IVPB; OXALIPLATIN 162 MG / 250 ML D5W IVPB; OXALIPLATIN 169 MG / 250 ML D5W IVPB; OXALIPLATIN 90 MG / 500 ML D5W IVPB; OXALIPLATIN 50 MG / 250 ML D5W IVPB; OXALIPLATIN 70 MG / 500 ML D5W IVPB; OXALIPLATIN 40 MG / 250 ML D5W IVPB; OXALIPLATIN 155 MG / 250 ML D5W IVPB; OXALIPLATIN 85 MG / 250 ML D5W IVPB OXALIPLATIN 146 MG / 250 ML D5W IVPB; OXALIPLATIN 246 MG / 500 ML D5W IVPB; OXALIPLATIN 143 MG / 250 ML D5W IVPB; OXALIPLATIN 65 MG / 500 ML D5W IVPB; OXALIPLATIN 80 MG / 500 ML D5W IVPB; OXALIPLATIN 100 MG / 250 ML D5W IVPB; OXALIPLATIN 150 MG / 250 ML D5W IVPB; OXALIPLATIN 125 MG / 250 ML D5W IVPB; OXALIPLATIN 170 MG / 250 ML D5W IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

D-1797-2019

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-1797-2019

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