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Recall Observatory FDA recall evidence

Drug product

fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3479, PharMEDium.

D-723-2016

January 13, 2015

Class I

Product summary

Firm
Pharmedium Services, LLC
Event
Event 72380
Status
Terminated
Classification
Class I
Quantity
180 syringes
Official record key
drug-enforcement:D-723-2016

Official wording

Reason: Subpotent Drug

Code information: Lot #: 15002077M, Exp 04-02-2015

Distribution pattern: Nine specific hospital pharmacies in VA, IA, WI, CO, CA, PA, and OK.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent