Recalls / Class II
Class IID-0595-2016
Product
Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Affected lot / code info
- All lots with expiration dates up to 11/17/2015
Why it was recalled
Stability data does not support expiry.
Recalling firm
- Firm
- Pharmakon Pharmaceuticals
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14450 Getz Rd, N/A, Noblesville, Indiana 46060-3303
Distribution
- Quantity
- 665
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-08-19
- FDA classified
- 2016-01-27
- Posted by FDA
- 2016-02-03
- Terminated
- 2017-05-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0595-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.