FDA-Drug2017-03-22Class III

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

Pharmedium Services, LLC
Hazard

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

Sold states
Nationwide
Affected count
3879 syringes
Manufactured in
150 N Field Dr Ste 350, N/A, Lake Forest, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0603-2017

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