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Recall Observatory FDA recall evidence

Drug product

fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174.

D-0093-2017

July 17, 2015

Class I

Product summary

Firm
Pharmedium Services, LLC
Event
Event 73925
Status
Terminated
Classification
Class I
Quantity
500 syringes
Official record key
drug-enforcement:D-0093-2017

Official wording

Reason: Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in syringes.

Code information: Lot Number: 15149004M, Exp 08/27/15

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent