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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-0035-2017

July 17, 2015

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 73925
Status
Terminated
Classification
Class II
Quantity
8955 syringes
Official record key
drug-enforcement:D-0035-2017

Official wording

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

Code information: Lot Numbers: 15118074M, 15120007M, 15124007M, 15127060M, 15132006M, 15132039M, 15138059M, 15139012M, 15139051M, 15140003M, 15141067M, 15146006M, 15148075M, 151730112M, 151730155M, 151740205M, 151880329M, 151930020M, 151930026M, 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