FDA recall D-1567-2019

Wise Pharmacy · Class II · drug

Product

Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise Pharmacy, Littleton, CO 80123.

Reason for recall

Lack of Processing Controls

Distribution

CO, TX, WY

Key facts

Status
Terminated
Initiation date
2019-07-22
Report date
2019-08-07
Termination date
2020-02-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Littleton, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1567-2019