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Recall Observatory FDA recall evidence

Drug product

lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 3 mL in a syringe, Rx only, PharMEDium, Product code 2R3343.

D-0091-2017

July 17, 2015

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 73925
Status
Terminated
Classification
Class II
Quantity
4400 syringes
Official record key
drug-enforcement:D-0091-2017

Official wording

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

Code information: Lot Numbers: 15118063M, 15119033M, 15124035M, 15132062M, 15135014C, 15138006M, 15146004M, 15147009C, 15152042M, 15155003C, 15160004C, 151680013C, 151730130M, 151900142M, 151950033M, 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