Pharmakon Recalls Rocuronium Syringes Due to Stability Data Concerns
Pharmakon Pharmaceuticals is recalling 5,875 units of Rocuronium 10 mg/mL syringes because stability data does not support the expiration dates.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 involves a potential stability issue without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 5,875 units of Rocuronium 10 mg/mL, injectable packed in syringes. The product is a prescription-only medication with a total dosage of 50 mg per 5 mL. 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. The agency has classified this recall as Class II. The product was distributed nationwide.
Healthcare providers and patients should stop using the affected product and contact Pharmakon Pharmaceuticals for further instructions or a replacement.
The recalled product
- Product
- Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Manufacturer
- Pharmakon Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- Affected units
- 5,875
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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