The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0091-2017·Announced 2016-10-19

Pharmedium Recalls Lidocaine Syringes Due to Stability Data Concerns

Pharmedium Services, LLC is recalling 4,400 syringes of lidocaine HCl 1% 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe severity score according to the rubric, as it involves a potential loss of potency in a prescription medication.

Plain-English summary

Pharmedium Services, LLC is recalling 4,400 syringes of lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 3 mL in a syringe, Rx only, Product code 2R3343. The recall is being conducted because stability data does not support the expiration 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 U.S. Food and Drug Administration has classified this as a Class II recall.

Healthcare providers and patients should stop using the affected syringes and contact Pharmedium Services, LLC for further instructions or a replacement. Consumers should verify the lot numbers and expiration dates on their packaging to determine if they are affected.

The recalled product

Product
lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 3 mL in a syringe, Rx only, PharMEDium, Product code 2R3343.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable Anesthetic
Hazard
Affected units
4,400

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 (16)

  • Lot Numbers: 15118063M
  • 15119033M
  • 15124035M
  • 15132062M
  • 15135014C
  • 15138006M
  • 15146004M
  • 15147009C
  • 15152042M
  • 15155003C
  • 15160004C
  • 151680013C
  • 151730130M
  • 151900142M
  • 151950033M
  • 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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