FDA recall D-643-2013
Clinical Specialties Compounding Pharmacy · Class II · drug
Product
HCG 1000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Reason for recall
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Distribution
FL, GA and SC.
Key facts
- Status
- Terminated
- Initiation date
- 2013-03-20
- Report date
- 2013-07-10
- Termination date
- 2017-02-22
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Augusta, GA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-643-2013