Pharmakon Recalls Morphine Sulfate Syringes Due to Stability Data Concerns
Pharmakon Pharmaceuticals is recalling 475 syringes of Morphine Sulfate (PF) 0.5 mg/mL 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, and the hazard is a theoretical stability issue without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 475 syringes of Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride. The product is an injectable, prescription-only medication. The recall is being conducted because stability data does not support the expiration dates assigned to the product.
The affected lots are all those with expiration dates up to 11/17/2015. The recall is classified as Class II by the U.S. Food and Drug Administration. The product was distributed nationwide.
Healthcare providers and patients should stop using the affected product and contact Pharmakon Pharmaceuticals or their local FDA office for further instructions.
The recalled product
- Product
- Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Manufacturer
- Pharmakon Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- Affected units
- 475
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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