The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0041-2017·Announced 2016-10-19

Pharmedium Recalls Fentanyl Citrate Syringes Due to Stability Data Concerns

Pharmedium Services, LLC is recalling 616 syringes of fentanyl citrate because stability data does not support the expiry dates, posing a risk of loss of 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 situation that might cause temporary or medically reversible adverse health consequences. The specific hazard is a potential loss of potency due to stability data issues, which is a quality defect rather than a direct physical injury or contamination risk.

Plain-English summary

Pharmedium Services, LLC is recalling 616 syringes of fentanyl citrate, 10 mcg per mL (25 mcg per 2.5 mL), in 0.9% Sodium Chloride, 2.5 mL Total Volume in a syringe, For IV Use. The product is identified by Product code 2R3424 and is distributed nationwide.

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

The affected lot numbers are 15103031M, 15127041M, 15139034M, 15140039M, 15141048M, 15147057M, 15147086M, 15148053M, and 151880285M. These lots have expiration dates between 07/15/15 and 10/12/15. Healthcare providers and patients should stop using the affected product and contact Pharmedium Services, LLC for further instructions.

The recalled product

Product
fentaNYL Citrate, 10 mcg per mL (25 mcg per 2.5 mL), in 0.9% Sodium Chloride, 2.5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3424.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable Medication
Hazard
Affected units
616

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 (10)

  • Lot Numbers: 15103031M
  • 15127041M
  • 15139034M
  • 15140039M
  • 15141048M
  • 15147057M
  • 15147086M
  • 15148053M
  • 151880285M
  • 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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