Pharmedium Recalls Fentanyl Syringes Due to Potential Loss of Potency
Pharmedium Services, LLC is recalling 110 syringes of fentanyl citrate because stability data does not support the expiry date, posing a risk of reduced drug potency.
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 FDA has classified this recall as Class II. According to the severity rubric, an FDA Class II recall must be scored as 4 (Severe), as it indicates a potential for temporary or medically reversible adverse health consequences, such as loss of drug potency.
Plain-English summary
Pharmedium Services, LLC is recalling 110 syringes of fentanyl citrate, 25 mcg per mL in 0.9% Sodium chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only. The product is identified by Product code 2R3236 and specific lot numbers: 15140057M, 15147053M, and 15127066M, with expiration dates between 07/15/15 and 10/12/15. The recall is nationwide.
The recall was initiated because stability data does not support the expiry date for the drugs packaged and stored in syringes. This condition creates a potential for 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. The FDA has classified this recall as Class II, 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, 25 mcg per mL in 0.9% Sodium chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3236.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 110
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 (4)
- Lot Numbers: 15140057M
- 15147053M
- 15127066M
- 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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