Pharmakon Recalls Provocholine Pre-diluted Sets Due to Stability Data Issues
Pharmakon Pharmaceuticals is recalling Provocholine Pre-diluted Set II because stability data does not support the expiration dates. The recall covers all lots expiring through November 17, 2015.
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 is driven by a lack of stability data rather than reported injuries or confirmed contamination, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Pharmakon Pharmaceuticals is voluntarily recalling Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 mg/mL, 3 mL in 5 mL Syringes. The recall is being conducted because stability data does not support the expiration dates assigned to the product.
The recall includes all lots with expiration dates up to 11/17/2015. The product is distributed nationwide and is a prescription-only injectable medication. The FDA has classified this recall as Class II, 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 on returns or replacements.
The recalled product
- Product
- Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Manufacturer
- Pharmakon Pharmaceuticals
- Category
- Drug — Injectable Medication
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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