Pharmakon Recalls Subpotent Epinephrine Injectable Syringes Nationwide
Pharmakon Pharmaceuticals is recalling 1,150 syringes of Epinephrine (PF) 10 mcg/mL because the drug was found to be subpotent. The recall is voluntary and nationwide.
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 the hazard involves a subpotent drug (epinephrine), which is a risk-of-harm product where injury has not been explicitly reported in the source text.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is voluntarily recalling 1,150 syringes of Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable. The product is prescription-only and distributed nationwide. The recall was initiated on August 19, 2015, and was classified as Class II by the FDA.
The reason for the recall is that the drug was found to be subpotent, meaning it contained less of the active ingredient than labeled. The recall covers all lots with expiration dates up to November 17, 2015. The recall was initiated by the firm and notified via telephone.
The recall status is currently terminated as of May 9, 2017. Patients and healthcare providers should check their inventory for affected lots and contact their pharmacist or the manufacturer for further instructions.
The recalled product
- Product
- Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Manufacturer
- Pharmakon Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1,150
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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