FDA recall D-0385-2017
Wells Pharmacy Network LLC · Class II · drug
Product
QUAD4 (PAP/PHEN/ALPROS/ATRO) 30 mg/3 mg/60 mcg/0.2 mg/mL Injectable, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Reason for recall
Lack of Assurance of Sterility
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2016-09-21
- Report date
- 2017-01-11
- Termination date
- 2021-07-02
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Ocala, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0385-2017