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Recall Observatory FDA recall evidence

Drug product

RITUXAN 728 MG QS 728 mL 0.9% NACL IVPB; RITUXAN 560 MG / 306 ml 0.9% NACL; RITUXAN 562 MG IN 562 ml 0.9% NACL; RITUXAN 700 MG QS 700 mL 0.9% NACL IVPB; RITUXAN 1000 MG / 350 mL 0.9% NACL IVPB RITUXAN 730 MG / 730 mL 0.9% NACL IVPB; RITUXAN 1000 MG QS 1000 ml NS; RITUXAN 1000 MG QS 200 ml 0.9% NACL; RITUXAN 500 MG / 300 ml 0.9% NACL; RITUXAN 660 MG QS 660 ml 0.9% NACL; RITUXAN 770 MG QS 770 mL 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

D-1809-2019

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-1809-2019

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