The Recall Desk
ModerateFDA (Drugs)·D-0043-2017·Announced 2016-10-19

Pharmedium Recalls Fentanyl Citrate Syringes Due to Stability Data Concerns

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

What this means for you

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 recall.

Plain-English summary

Pharmedium Services, LLC is recalling 10 syringes of fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a 3 mL BD Syringe, For IV Use Only. The product is identified by Product code 2T6107 and Lot Number 151900252M, 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 may result in a potential loss of potency in the drugs packaged and stored in syringes.

The affected product was distributed nationwide. This recall is classified as Class II by the U.S. Food and Drug Administration. The hazard is a potential loss of potency, meaning the medication may not be as effective as intended.

Healthcare providers and patients should stop using the affected product and contact Pharmedium Services, LLC for further instructions or a replacement. Consumers should not use the recalled syringes and should return them to the pharmacy or healthcare provider where they were obtained.

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 3 mL BD Syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6107.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable Medication
Hazard
Affected units
10

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: 151900252M
  • 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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