Pharmakon Recalls Fentanyl Citrate Syringes Due to Stability Data Issues
Pharmakon Pharmaceuticals is recalling Fentanyl Citrate syringes because stability data does not support the expiration dates. The recall covers 7,100 units distributed nationwide.
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 the source text indicates a theoretical hazard regarding stability data without reporting specific injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Pharmakon Pharmaceuticals is recalling Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes. The product is available in two total dosage configurations: 250 mcg/5mL and 100 mcg/2mL. It is a prescription-only medication.
The recall was initiated because stability data does not support the expiration dates for the product. The recall includes all lots with expiration dates up to 11/17/2015. A total of 7,100 units were distributed nationwide.
Healthcare providers and patients should stop using the recalled product and contact Pharmakon Pharmaceuticals or their healthcare provider for further instructions.
The recalled product
- Product
- Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/ 5mL, b) Total dosage 100 mcg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Manufacturer
- Pharmakon Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- Affected units
- 7,100
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 (1)
- All lots with expiration dates up to 11/17/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Pharmakon Pharmaceuticals 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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