FDA Recall D-1565-2014
Pharmakon Pharmaceuticals · Noblesville, IN
Class I — life-threatening Terminated 226 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Reason for recall
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Recall record
- Recall number
D-1565-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- United States: TX, IL, MD, IN
- Recall initiated
- 2014-04-21
- Classified by FDA Center
- 2014-08-26
- FDA published
- 2014-09-03
- Terminated
- 2014-12-03
- Recalling firm
- Pharmakon Pharmaceuticals
- Firm location
- Noblesville, IN