FDA recall D-0282-2017
Tri-Coast Pharmacy · Class II · drug
Product
Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/3mg/30mg/200mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
Reason for recall
Lack of Assurance of Sterility
Distribution
Nationwide
Key facts
- Status
- Ongoing
- Initiation date
- 2016-11-17
- Report date
- 2017-01-11
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Juno Beach, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0282-2017