The Recall Desk
ModerateFDA (Drugs)·D-0059-2017·Announced 2016-10-19

Pharmedium Recalls Lidocaine Syringes Due to Potential Loss of Potency

Pharmedium Services, LLC is recalling 3,285 syringes of lidocaine HCl because stability data does not support the expiry date, posing a risk of reduced drug potency.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which is a reasonable probability of temporary or medically reversible health consequences. The hazard is a potential loss of potency rather than a direct injury or contamination, fitting the Moderate severity criteria for low-risk issues without reported illness.

Plain-English summary

Pharmedium Services, LLC is voluntarily recalling 3,285 syringes of lidocaine HCl, 0.5%, 5 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume. The product is prescription-only and was distributed nationwide. The recall is due to stability data that does not support the expiry date, which creates a potential for loss of potency in the drugs packaged and stored in syringes.

The affected product is identified by Product code 2R3140. Specific lot numbers include 15118068M, 15124072M, 15125066M, 15128033M, 15131001M, 15131017M, 15139035M, 15139080M, 15146036M, 15147054M, 15152078M, 151730126M, 151740218M, and 151900292M. These lots have expiration dates between 07/15/15 and 10/12/15.

Healthcare providers and patients should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be discontinued and returned to the distributor or manufacturer. Consumers should not use the recalled syringes and should contact their healthcare provider for further instructions.

The recalled product

Product
lidocaine HCl, 0.5%, 5 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3140.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable Anesthetic
Hazard
Affected units
3,285

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 (14)

  • Lot Numbers: 15118068M
  • 15124072M. 15125066M
  • 15128033M
  • 15131001M
  • 15131017M
  • 15139035M
  • 15139080M
  • 15146036M
  • 15147054M
  • 15152078M
  • 151730126M
  • 151740218M
  • 151900292M
  • Exp between 07/15/15-10/12/15

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 69 recalled by Pharmedium Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 69 products in this recall →

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