FDA recall D-0012-2015
Unique Pharmaceutical, Ltd · Class II · drug
Product
All sterile products within expiry
Reason for recall
Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2014-07-18
- Report date
- 2014-10-15
- Termination date
- 2016-02-24
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Temple, TX, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0012-2015