Pharmedium Recalls Fentanyl Citrate Injection Syringes Due to Stability Concerns
Pharmedium Services, LLC is recalling 53,357 syringes of fentanyl citrate injection because stability data does not support the expiry dates, posing a risk of loss of 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific hazard is a potential loss of potency, which is a significant quality issue but does not involve acute toxicity or immediate severe injury, fitting the Moderate category for a voluntary precautionary recall regarding stability.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling 53,357 syringes of fentanyl citrate injection, 50 mcg per mL (100 mcg per 2 mL), 2 mL total volume, for IV use. The product is identified by product code 2R3303 and various lot numbers with expiration dates between July 15, 2015, and October 12, 2015.
The recall was initiated because stability data does not support the expiry dates for drugs packaged and stored in syringes. This condition creates a potential for loss of potency in the medication.
The affected product was distributed nationwide. Healthcare providers and patients should stop using the recalled syringes and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- fentaNYL Citrate Injection, 50 mcg per mL (100 mcg per 2 mL), 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3303.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Affected units
- 53,357
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 (20)
- Lot Numbers: 15119083M
- 15119086M
- 15133078M
- 15134127M
- 15135064M
- 151380066M
- 15138007M
- 151380108M
- 151380109M
- 15138060M
- 15138063M
- 15138064M
- 15138065M
- 15140043M
- 15140082M
- 15140084M
- 15142093M
- 151450033M
- 151460093M
- 151460094M
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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