Pharmakon Recalls Ephedrine Sulfate Syringes Due to Stability Data Issues
Pharmakon Pharmaceuticals is recalling Ephedrine Sulfate 5 mg/mL 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, injuries, or hospitalizations. The hazard is theoretical, relating to stability data rather than a confirmed contamination or defect causing harm.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes. The product is a prescription-only medication with a total dosage of 25 mg per 5 mL.
The recall was initiated because stability data does not support the expiration dates for the affected units. The recall covers 4,123 units distributed nationwide. All lots with expiration dates up to 11/17/2015 are included in this recall.
Healthcare providers and patients should stop using the recalled product and contact Pharmakon Pharmaceuticals or their supplier for further instructions.
The recalled product
- Product
- Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Manufacturer
- Pharmakon Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- Affected units
- 4,123
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.
See all 22 products in this recall →Related recalls
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