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Recall Observatory FDA recall evidence

Drug product

Doxorubicin Liposomal 71 MG / 250 ML D5W IVPB; Doxorubicin Liposomal 66 MG/250 ML D5W, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 Doxorubicin 16 MG/1000 ML NS IV WITH Vincristine 0.6 MG and Etoposide 78 MG Doxorubicin 16 MG/1000 ML NS IV WITH Vincristine 0.6 MG and Etoposide 78 MG Duplicate Doxorubicin 45 MG / 22.5 ML IVP SYRINGE

D-1771-2019

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-1771-2019

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