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Recall Observatory FDA recall evidence

Drug product

Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, NDC 25021-0113-82

D-0780-2016

March 01, 2016

Class II

Product summary

Firm
Sagent Pharmaceuticals Inc
Event
Event 73434
Status
Terminated
Classification
Class II
Quantity
37,450 bags
Official record key
drug-enforcement:D-0780-2016

Official wording

Reason: Cross contamination with other products: metronidazole

Code information: Lot #: 40608, Exp 5/17

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cross contamination with other products: metronidazole