The Recall Desk
SevereFDA (Drugs)·D-0042-2017·Announced 2016-10-19

Pharmedium Recalls Fentanyl Syringes Due to Potential Loss of Potency

Pharmedium Services, LLC is recalling 1,735 syringes of fentanyl citrate because stability data does not support the expiration dates, posing a risk of reduced drug potency.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall with potential for significant harm (loss of potency in a potent opioid) is categorized as Severe (Score 4), as it is not Class I but involves a significant risk of adverse health consequences.

Plain-English summary

Pharmedium Services, LLC is recalling 1,735 syringes of fentanyl citrate, 5 mcg per mL, 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use. The recall is due to stability data that does not support the expiration dates, which creates a potential for loss of potency in the drugs packaged and stored in syringes.

The affected product is identified by Product code 2R3479. The recall includes specific lot numbers: 15119048M, 15126024M, 15127055M, 15133037M, 15135039M, 15138039M, 15140022M, 15141026M, 15148023M, 15152075M, 151730221M, 151890289M, and 151900214M. These lots have expiration dates between 07/15/15 and 10/12/15. The product was distributed nationwide.

Healthcare providers and patients should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be stopped and returned to the distributor or manufacturer. This recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
fentaNYL Citrate, 5 mcg per mL, 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3479.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable Opioid
Hazard
Affected units
1,735

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 (14)

  • Lot Numbers: 15119048M
  • 15126024M
  • 15127055M
  • 15133037M
  • 15135039M
  • 15138039M
  • 15140022M
  • 15141026M
  • 15148023M
  • 15152075M
  • 151730221M
  • 151890289M
  • 151900214M
  • 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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