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Recall Observatory FDA recall evidence

Drug product

lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 1 mL in a syringe, Rx only, PharMEDium, Product code 2R3345.

D-0063-2017

July 17, 2015

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 73925
Status
Terminated
Classification
Class II
Quantity
5900 syringes
Official record key
drug-enforcement:D-0063-2017

Official wording

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

Code information: Lot numbers: 15118046M, 15128003M, 15128111M, 15133006M, 15139004M, 15140015C, 15146086M, 15150029M, 15153004M, 151660012C, 151720052C, 151730131C, 151740007C, 151750019C, 151760011C, 151800048C,151880154M, 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