The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0603-2017·Announced 2017-03-22

Pharmedium Recalls Buffered Lidocaine Syringes Due to Labeling Error

Pharmedium Services, LLC is recalling 3,879 syringes of Buffered Lidocaine because the outer packaging is incorrectly labeled as 1% instead of 0.9%.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a minor labeling error.

Plain-English summary

Pharmedium Services, LLC is voluntarily recalling 3,879 syringes of Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL syringe. The product is a prescription-only local anesthetic. The recall is due to a labeling error where the outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of the correct Buffered Lidocaine 0.9%.

The affected lot numbers are 170110030M, 170110029M, and 170070058M. The product was distributed nationwide. The U.S. Food and Drug Administration has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

Healthcare providers and patients should check their inventory for the specific lot numbers listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer. No specific consumer action is required for the general public, as this is a prescription product.

The recalled product

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
Manufacturer
Pharmedium Services, LLC
Category
Drug — Local Anesthetic
Hazard
Affected units
3,879

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot Numbers: 170110030M
  • 170110029M and 170070058M

Distribution

Distributed nationwide across the United States.

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