Pharmakon Recalls Midazolam HCl Vials Due to Undeclared Benzyl Alcohol
Pharmakon Pharmaceuticals is recalling specific lots of Midazolam HCl 2 mg/ml vials because they contain undeclared benzyl alcohol.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly identifies this as an FDA Class I recall, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 20 vials of Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vials. The recall affects Lot # E21294K3C with an expiration date of 6/29/2014. The product is identified by NDC # 45183-0234-68.
The recall was initiated because the product contains undeclared benzyl alcohol. This is a Class I recall, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The affected product was distributed in Texas, Illinois, Maryland, and Indiana. Healthcare providers and patients should stop using the affected vials and contact Pharmakon Pharmaceuticals or their local FDA office for further instructions.
The recalled product
- Product
- Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68.
- Manufacturer
- Pharmakon Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- Affected units
- 20
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)
- Lot #: E21294K3C Exp Date: 6/29/2014
Distribution
Part of a larger recall action
This product is one of 4 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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