Pharmakon Recalls Phenylephrine Syringes Due to Stability Data Issues
Pharmakon Pharmaceuticals is recalling Phenylephrine injectable syringes because stability data does not support the expiration dates.
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, but the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes. The product is a prescription-only medication with a total dosage of 500 mcg per 5mL.
The recall was initiated because stability data does not support the expiration dates for the affected lots. The recall includes all lots with expiration dates up to 11/17/2015. The product was distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Manufacturer
- Pharmakon Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
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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