Pharmedium Recalls Fentanyl Citrate Injection Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 997 syringes of fentanyl citrate injection because stability data does not support the expiry date, posing a potential loss of potency.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a potent opioid medication where loss of potency could lead to inadequate pain management or respiratory depression if dosing is adjusted incorrectly, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Pharmedium Services, LLC is recalling 997 syringes of fentanyl citrate injection, 50 mcg per mL, 250 mcg per 5 mL, 5mL Total Volume in a syringe, For IV Use, Rx only, Product code 2R3306. The recall is being conducted because stability data does not support the expiry date for the product, which may result in a potential loss of potency in drugs packaged and stored in syringes.
The affected product is distributed nationwide. The specific lot numbers involved are 15112083M and 15112129M, with expiration dates between 07/15/15 and 10/12/15. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected fentanyl citrate injection syringes and contact Pharmedium Services, LLC for further instructions or a replacement. Consumers should verify the lot number and expiration date on their product packaging to determine if it is affected by this recall.
The recalled product
- Product
- fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL, 5mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3306.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injection
- Affected units
- 997
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 (3)
- Lot Numbers: 15112083M
- 15112129M
- 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.
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