Pharmakon Recalls Midazolam Syringes Due to Insufficient Stability Data
Pharmakon Pharmaceuticals is recalling 665 syringes of Midazolam (PF) because stability data does not support the expiration dates. The recall is nationwide.
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 the source text indicates a documentation/stability issue without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 665 syringes of Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable. The product is a prescription-only medication with a total dosage of 0.2 mg per 2 mL syringe.
The recall is being conducted because stability data does not support the expiration dates for the affected lots. The recall covers all lots with expiration dates up to 11/17/2015. The product was distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact Pharmakon Pharmaceuticals or their supplier for further instructions.
The recalled product
- Product
- Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Manufacturer
- Pharmakon Pharmaceuticals
- Category
- Drug — Injectable
- Affected units
- 665
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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