FDA Recall D-1362-2014
Pharmakon Pharmaceuticals · Noblesville, IN
Class I — life-threatening Terminated 127 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Reason for recall
Superpotent Drug: Product contains twice the stated amount of midazolam.
Recall record
- Recall number
D-1362-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- IN
- Recall initiated
- 2014-03-26
- Classified by FDA Center
- 2014-06-09
- FDA published
- 2014-06-18
- Terminated
- 2014-07-31
- Recalling firm
- Pharmakon Pharmaceuticals
- Firm location
- Noblesville, IN