The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0068-2017·Announced 2016-10-19

Pharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns

Pharmedium Services, LLC is recalling 1,161 syringes of lidocaine HCl 2% because stability data does not support the expiration dates, posing a risk of reduced potency.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

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 typically involves a temporary or medically reversible adverse health consequence. The specific hazard is a potential loss of potency rather than a direct physical injury or contamination, fitting the Moderate severity criteria for low-risk contamination or labeling/potency issues without reported serious harm.

Plain-English summary

Pharmedium Services, LLC is recalling 1,161 syringes of lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume. The product is identified by Product code 2R3441 and NDC 61553-441-80. The recall covers specific lot numbers with expiration dates between 07/15/15 and 10/12/15.

The recall was initiated because stability data does not support the expiration dates for the drugs packaged and stored in syringes. This condition creates a potential for loss of potency in the medication. The affected product was distributed nationwide.

Consumers and healthcare providers should stop using the recalled syringes and contact Pharmedium Services, LLC for further instructions or a replacement.

The recalled product

Product
lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume, Product code 2R3441, NDC 61553-441-80
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
1,161

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 (7)

  • Lot Numbers: 15121068M
  • 15128035M
  • 15134056M
  • 15148067M
  • 15152003M
  • 151890376M
  • 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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