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Recall Observatory FDA recall evidence

Drug product

lidocaine HCl, 0.5%, 5 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3140.

D-0059-2017

July 17, 2015

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 73925
Status
Terminated
Classification
Class II
Quantity
3285 syringes
Official record key
drug-enforcement:D-0059-2017

Official wording

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

Code information: Lot Numbers: 15118068M, 15124072M. 15125066M, 15128033M, 15131001M, 15131017M, 15139035M, 15139080M, 15146036M, 15147054M, 15152078M, 151730126M, 151740218M, 151900292M, 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