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Recall Observatory FDA recall evidence

Drug product

DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047. NDC: 63323-883-05

D-0105-2021

November 17, 2020

Class III

Product summary

Firm
Fresenius Kabi USA, LLC
Event
Event 86765
Status
Terminated
Classification
Class III
Quantity
16,986 vials
Official record key
drug-enforcement:D-0105-2021

Official wording

Reason: Cross Contamination with Other Products: trace amounts of octreotide found during testing

Code information: Batch: 6120525, exp 11/2020

Distribution pattern: Nationwide USA and Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cross Contamination with Other Products: trace amounts of octreotide found during testing