FDA recall D-0331-2017

Wells Pharmacy Network LLC · Class II · drug

Product

Phenylephrine HCl Injectable, 1 mg/mL (0.1%), 5 mL vial, 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-0331-2017