The Recall Desk
ModerateFDA (Drugs)·D-0063-2017·Announced 2016-10-19

Pharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns

Pharmedium Services, LLC is recalling 5,900 syringes of lidocaine HCl 1% because stability data does not support the expiry dates, posing a risk of loss of 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 typically associated with a temporary or medically reversible adverse health consequence. The specific hazard is a potential loss of potency, which is a lower-risk issue compared to contamination or serious injury, fitting the Moderate severity criteria for a voluntary precautionary recall without reported illness.

Plain-English summary

Pharmedium Services, LLC is voluntarily recalling 5,900 syringes of lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 1 mL in a syringe, Rx only, Product code 2R3345. The recall is being conducted because stability data does not support the expiry dates for the product, which may result in a potential loss of potency in the drugs packaged and stored in syringes.

The affected product was distributed nationwide. The recall covers specific lot numbers with expiration dates between 07/15/15 and 10/12/15. The affected lot numbers are: 15118046M, 15128003M, 15128111M, 15133006M, 15139004M, 15140015C, 15146086M, 15150029M, 15153004M, 151660012C, 151720052C, 151730131C, 151740007C, 151750019C, 151760011C, 151800048C, and 151880154M.

Healthcare providers and patients should check their inventory and records for these specific lot numbers and expiration dates. If the product is found, it should be stopped from use and returned to the distributor or the recalling firm, Pharmedium Services, LLC, for credit or replacement.

The recalled product

Product
lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 1 mL in a syringe, Rx only, PharMEDium, Product code 2R3345.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable Anesthetic
Hazard
Affected units
5,900

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 (18)

  • Lot numbers: 15118046M
  • 15128003M
  • 15128111M
  • 15133006M
  • 15139004M
  • 15140015C
  • 15146086M
  • 15150029M
  • 15153004M
  • 151660012C
  • 151720052C
  • 151730131C
  • 151740007C
  • 151750019C
  • 151760011C
  • 151800048C
  • 151880154M
  • 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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