The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-1825-2015·Announced 2015-09-30

PharMEDium Recalls Fentanyl Citrate IV Bags Due to Particulate Matter

PharMEDium Services, LLC is recalling 663 bags of Fentanyl Citrate IV solution because the sodium chloride used contained human hair.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 I, which mandates a minimum severity score of 4 per the rubric.

Plain-English summary

PharMEDium Services, LLC is recalling 663 bags of Fentanyl Citrate, 5 mcg per mL, 250 mL IV solution. The product is distributed nationwide and is identified by specific lot numbers and expiration dates ranging from January 2015 to February 2015.

The recall was initiated because the product was manufactured using Hospira 0.9% Sodium Chloride, USP injection that was previously recalled due to the presence of particulate matter, specifically human hair.

Healthcare providers and patients should check their inventory for the affected lot numbers and stop using the product. The source text does not provide specific instructions for disposal or return, but the presence of particulate matter in an IV solution poses a risk to patients.

The recalled product

Product
Fentanyl Citrate, 5 mcg per mL (1,250 mcg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-107-50
Manufacturer
Pharmedium Services, LLC
Category
Drug — IV Solution
Hazard
Affected units
663

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 #: 14303122M
  • Exp 01/28/15
  • 14309029M
  • Exp 02/02/15
  • 14315067M
  • Exp 02/09/15
  • 14317040M
  • Exp 02/11/15
  • 14318026M
  • Exp 02/12/15
  • 14323089M
  • Exp 02/17/15
  • 14325128M
  • 14325124M
  • Exp 02/19/15

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 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 8 products in this recall →

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