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Recall Observatory FDA recall evidence

Drug product

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

D-0042-2017

July 17, 2015

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 73925
Status
Terminated
Classification
Class II
Quantity
1735 syringes
Official record key
drug-enforcement:D-0042-2017

Official wording

Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Code information: Lot Numbers: 15119048M, 15126024M, 15127055M, 15133037M, 15135039M, 15138039M, 15140022M, 15141026M, 15148023M, 15152075M, 151730221M, 151890289M, 151900214M, Exp between 07/15/15-10/12/15

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    loss of potency