Pharmakon Recalls Ondansetron Syringes Due to Insufficient Stability Data
Pharmakon Pharmaceuticals is recalling 4,100 units of Ondansetron 2 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 due to a labeling/stability issue (expiration date) without reported injuries or illnesses, fitting the 'Moderate' criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Pharmakon Pharmaceuticals is recalling 4,100 units of Ondansetron 2 mg/mL, injectable packed in syringes. The product is prescription-only and was distributed nationwide. The recall covers all lots with expiration dates up to 11/17/2015.
The recall was initiated because stability data does not support the expiration dates for the product. This is a Class II recall, indicating a situation that might cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected product and contact Pharmakon Pharmaceuticals or their supplier for further instructions.
The recalled product
- Product
- Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Manufacturer
- Pharmakon Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- Affected units
- 4,100
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.
See all 22 products in this recall →Related recalls
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