Pharmakon Recalls Midazolam Syringes Due to Insufficient Stability Data
Pharmakon Pharmaceuticals is recalling 5,000 syringes of Midazolam 1 mg/mL 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, but the source text explicitly states that stability data does not support the expiration dates, which is a documentation and labeling issue rather than a confirmed contamination or defect causing injury. This aligns with the rubric for minor labeling errors or voluntary precautionary recalls.
Plain-English summary
Pharmakon Pharmaceuticals is recalling 5,000 syringes of Midazolam 1 mg/mL in 0.9% Sodium Chloride. The product is an injectable medication with a total dosage of 2 mg per 2 mL, available by prescription only. The recall covers 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 affected units were distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact Pharmakon Pharmaceuticals for further instructions or a refund.
The recalled product
- Product
- Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Manufacturer
- Pharmakon Pharmaceuticals
- Category
- Drug — Injectable
- Affected units
- 5,000
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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