The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0033-2017·Announced 2016-10-19

Fentanyl Citrate Injection Recalled Due to Potential Loss of Potency

Pharmedium Services is recalling fentanyl citrate injection syringes because stability data does not support the expiration date, 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 involves a potential loss of potency without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Pharmedium Services, LLC is recalling fentanyl citrate injection, 50 mcg per mL, preservative free, 1 mL total volume in a syringe, for IV use. The recall involves 50 syringes with Lot Number 15141053M and expiration dates between 07/15/15 and 10/12/15. The product was distributed nationwide.

The recall was initiated because stability data does not support the expiration date for the drug when packaged and stored in syringes. This condition may result in a potential loss of potency in the medication.

Healthcare providers and patients should stop using the affected syringes and contact Pharmedium Services, LLC for further instructions or replacement. This recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Product code 2R3118, NDC 61553-118-40
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable Medication
Hazard
Affected units
50

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 (2)

  • Lot Number: 15141053M
  • 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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