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Recall Observatory FDA recall evidence

Drug product

Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466

D-0603-2017

January 27, 2017

Class III

Product summary

Firm
Pharmedium Services, LLC
Event
Event 76661
Status
Terminated
Classification
Class III
Quantity
3879 syringes
Official record key
drug-enforcement:D-0603-2017

Official wording

Reason: Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%

Code information: Lot Numbers: 170110030M, 170110029M and 170070058M

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling; Label Mixup