Pharmakon Recalls Subpotent Midazolam Injectable Syringes Nationwide
Pharmakon Pharmaceuticals is recalling 210 syringes of Midazolam (PF) 0.5 mg/mL because the drug is subpotent. The recall is voluntary and nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II due to a subpotent drug, which poses a risk of therapeutic failure but is not associated with reported serious injury or death, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is voluntarily recalling 210 syringes of Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride. The recall was initiated on August 19, 2015, and the product is distributed nationwide. The reason for the recall is that the drug is subpotent, meaning it contains less of the active ingredient than labeled.
The affected product is prescription-only and packed in syringes with a total dosage of 0.5 mg per 1 mL. All lots with expiration dates up to November 17, 2015, are included in this recall. The recall status is currently terminated, with a termination date of May 9, 2017.
Healthcare providers and patients should check their inventory for this specific product and lot expiration dates. If the product is found, it should be returned to the supplier or disposed of according to local regulations. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Manufacturer
- Pharmakon Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- Affected units
- 210
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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