Pharmakon Recalls Midazolam Syringes Containing Twice Stated Dosage
Pharmakon Pharmaceuticals is recalling specific lots of Midazolam syringes because they contain twice the stated amount of the drug.
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 agency classification is FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The rubric mandates a score of 5 for FDA Class I recalls.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 80 syringes of Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride. The product is labeled as a prescription-only medication with a total dosage of 0.4 mg per 2 mL. The recall involves specific lots identified by lot numbers E1016227C and E0433735C, with expiration dates of April 21, 2014, and April 20, 2014, respectively.
The recall was initiated because the product contains twice the stated amount of midazolam. This is classified as a superpotent drug issue, meaning the medication is significantly more concentrated than indicated on the label. The affected product was distributed in Indiana.
Healthcare providers and patients should stop using the affected syringes immediately. Consumers should check their medication for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be returned to the pharmacy or healthcare provider for disposal or replacement.
The recalled product
- Product
- Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per 2 mL, Rx Only, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd, Noblesville, Indiana, NDC 45183-0014-69.
- Manufacturer
- Pharmakon Pharmaceuticals
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 80
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 (4)
- Lot #: E1016227C
- Exp. 4/21/2014
- E0433735C
- Exp. 4/20/2014
Distribution
Distributed in 1 state:
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