FDA recall D-112-2013
New England Compounding Center · Class II · drug
Product
Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Center, Framingham, MA
Reason for recall
Lack of Assurance of Sterility
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2012-09-26
- Report date
- 2013-01-09
- Termination date
- 2016-10-07
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Framingham, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-112-2013