The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0035-2017·Announced 2016-10-19

Pharmedium Recalls Fentanyl Syringes Due to Potential Loss of Potency

Pharmedium Services is recalling 8,955 syringes of fentanyl citrate because stability data does not support the expiration dates, posing a risk of reduced drug 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, and the hazard is a potential loss of potency rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity rating.

Plain-English summary

Pharmedium Services, LLC is recalling 8,955 syringes of fentanyl citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free. The product is intended for intravenous use and is available by prescription only. The recall covers specific lot numbers with expiration dates between July 15, 2015, and October 12, 2015.

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

Healthcare providers and patients should stop using the affected syringes and contact Pharmedium Services for further instructions. Consumers should not attempt to use the product if they have questions regarding its stability or potency.

The recalled product

Product
fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable Medication
Hazard
Affected units
8,955

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 (20)

  • Lot Numbers: 15118074M
  • 15120007M
  • 15124007M
  • 15127060M
  • 15132006M
  • 15132039M
  • 15138059M
  • 15139012M
  • 15139051M
  • 15140003M
  • 15141067M
  • 15146006M
  • 15148075M
  • 151730112M
  • 151730155M
  • 151740205M
  • 151880329M
  • 151930020M
  • 151930026M
  • 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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