Food, drugs, devices › Pharmakon Pharmaceuticals
Drug recall: Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per 2 mL, Rx Only, Pharmakon Pharmaceuticals,
Pharmakon Pharmaceuticals (Noblesville, IN) initiated this drug recall on 26 Mar 2014; FDA lists 1 product record under event 67903, classified Class I.
FDA defines Class I as 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. 15% of the 313 drug enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 31 Jul 2014. Initiation: voluntary: firm initiated. Pharmakon Pharmaceuticals has 4 enforcement events on this register, with a median of 4 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Pharmakon Pharmaceuticals, Noblesville, IN.
Reason for recall
"Superpotent Drug: Product contains twice the stated amount of midazolam."
Distribution
"IN"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1362-2014 | 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. | 80 syringes | Class I | Terminated | 18 Jun 2014 |
Context
Other enforcement events for Pharmakon Pharmaceuticals
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 11 Feb 2016 | Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug, | Drug | Class I | 1 |
| 19 Aug 2015 | Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHAR | Drug | Class II | 22 |
| 21 Apr 2014 | Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd | Drug | Class I | 4 |
All 4 events for Pharmakon Pharmaceuticals
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Superpotent Drug: Product contains twice the stated amount of midazolam."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "IN"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 31 Jul 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.