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Recall Observatory FDA recall evidence

Drug product

lidocaine HCl, 1%, 10 mg per 1 mL, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3102.

D-0060-2017

July 17, 2015

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 73925
Status
Terminated
Classification
Class II
Quantity
2961 syringes
Official record key
drug-enforcement:D-0060-2017

Official wording

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

Code information: Lot Numbers: 15118064M, 15119066M, 15119075M, 15124006M, 15133061M, 15133066M, 15134057M, 15140063M, 15149053M, 151720021M, 151880315M, 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