Pharmakon Recalls Morphine Sulfate Syringes Due to Stability Data Issues
Pharmakon Pharmaceuticals is recalling 525 syringes of Morphine Sulfate 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, which typically corresponds to a Moderate severity score when no specific injuries or hospitalizations are reported in the source text.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 525 syringes of Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride. The product is an injectable, prescription-only medication distributed nationwide. The recall affects 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 an FDA Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and patients should stop using the affected syringes and contact Pharmakon Pharmaceuticals for further instructions or a replacement.
The recalled product
- Product
- Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Manufacturer
- Pharmakon Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- Affected units
- 525
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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