FDA recall D-709-2013
Lowlite Investments, Inc. D/B/A Olympia Pharmacy · Class II · drug
Product
Caco/Copper 6. 2 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Reason for recall
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Distribution
Nationwide and PR
Key facts
- Status
- Ongoing
- Initiation date
- 2013-05-29
- Report date
- 2013-07-17
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Orlando, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-709-2013