CLASS I Drug recall · Reported 18 Jun 2014 · FDA Enforcement Report
Midazolam 0.2 mg/ 0.9% Sodium Chloride syringes recalled
Pharmakon Pharmaceuticals is recalling Midazolam 0.2 mg/ 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per, distributed in Indiana. The recall was initiated on 26 Mar 2014 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1362-2014
- FDA event ID
- 67903
- Recalling firm
- Pharmakon Pharmaceuticals, Noblesville, IN
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 26 Mar 2014
- FDA classified
- 9 Jun 2014
- Reported
- 18 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Mar 2014 | Recall initiated by company | |
| 9 Jun 2014 | Classified by FDA | +75 days |
| 18 Jun 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent Drug: Product contains twice the stated amount of midazolam.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
IN
Questions about this recall
Why was it recalled?
Superpotent Drug: Product contains twice the stated amount of midazolam.
Which lots are affected?
Lot #: E1016227C, Exp. 4/21/2014; E0433735C, Exp. 4/20/2014
Where was it sold?
IN
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Pharmakon Pharmaceuticals
All 116| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Succinylcholine Chloride 20 mg/mL BD syringe recalled | Pharmakon Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Ketamine 20 mg/mL in 0.9% Sodium Chloride lntravia recalled | Pharmakon Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride fill recalled | Pharmakon Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Ketamine 50mg/mL in 0.9% Sodium Chloride fill in syringe recalled | Pharmakon Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Cefazolin 2GM added to 5% Dextrose recalled by Pharmakon Pharmaceuticals | Pharmakon Pharmaceuticals | Sterility | Nationwide |
Other Midazolam recalls
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Midazolam HCl 100 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS I | Midazolam in 0.8% Sodium Chloride Injection 100 mg recalled | Exela Pharma Sciences | Particulate Matter | Nationwide |
| Drug | CLASS II | midazolam in dextrose 5%, 50 mg/, (1 mg/mL) Syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | midazolam in dextrose 5%, 50 mg /, (1 mg/mL) Syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | Midazolam Injection, USP, 50 mg/ (5mg/mL) recalled by Akorn | Akorn | Potency & Assay | Nationwide |