The Recall Desk
SevereFDA (Drugs)·D-0040-2017·Announced 2016-10-19

Pharmedium Recalls Fentanyl Syringes Due to Stability Data Concerns

Pharmedium Services is recalling 1,561 syringes of fentanyl citrate because stability data does not support the expiry dates, posing a risk of potency loss.

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. Per the rubric, FDA Class II recalls with potential for significant harm (loss of potency in a potent opioid) are categorized as Severe (Score 4), as they do not meet the 'unlikely to cause adverse health consequences' criteria of Class III.

Plain-English summary

Pharmedium Services, LLC is recalling 1,561 syringes of fentanyl citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a syringe, For IV Use. The product is identified by Product code 2R3339 and 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 expiry dates, which creates a potential for loss of potency in the drugs packaged and stored in syringes.

The affected product was distributed nationwide. This recall is classified as FDA Class II by the U.S. Food and Drug Administration. No specific illnesses or injuries have been reported in the source text.

Healthcare providers and patients should stop using the affected syringes and contact Pharmedium Services or their local FDA office for further instructions on how to return or dispose of the product.

The recalled product

Product
fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3339.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
1,561

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 (15)

  • Lot Numbers: 15103037M
  • 15117042M
  • 15126027M
  • 15127049M
  • 15131003M
  • 15119043M
  • 15138050M
  • 15141033M
  • 15142056M
  • 15146040M
  • 15149039M
  • 151890299M
  • 151900220M
  • 151930019M
  • 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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Same hazard · loss of potency

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