Pharmakon Recalls Provocholine Pre-diluted Sets Due to Stability Data Concerns
Pharmakon Pharmaceuticals is recalling 378 units of Provocholine Pre-diluted Set II because stability data does not support the expiration dates. The recall covers lots expiring up to 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 the hazard involves potential instability of the drug product without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 378 units of Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 mL Syringes. The product is an injectable, prescription-only medication distributed nationwide.
The recall was initiated because stability data does not support the expiration dates assigned to the product. The recall includes all lots with expiration dates up to November 17, 2015.
Healthcare providers and patients should stop using the recalled product and contact Pharmakon Pharmaceuticals or their supplier for further instructions.
The recalled product
- Product
- Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Manufacturer
- Pharmakon Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- Affected units
- 378
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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