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Recall Observatory FDA recall evidence

Drug product

Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

D-1744-2019

June 12, 2019

Class II

Product summary

Firm
Infusion Options, Inc.
Event
Event 83136
Status
Terminated
Classification
Class II
Quantity
820 60 units/bag
Official record key
drug-enforcement:D-1744-2019

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