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Recall Observatory FDA recall evidence

Drug product

lidocaine HCl, 2%, Preservative Free, Total Volume 2mL, Product code 2R3323, NDC 61553-323-79

D-0066-2017

July 17, 2015

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 73925
Status
Terminated
Classification
Class II
Quantity
830 syringes
Official record key
drug-enforcement:D-0066-2017

Official wording

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

Code information: Lot Numbers: 15119047M, 15124043M, 151340072M, 15134037M, 15148042M, 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