FDA recall D-1156-2017

Bella Pharmaceuticals, Inc. · Class II · drug

Product

Lidocaine Ophthalmic Gel 3.5%, 15mL bottles, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1(877) BELLA.

Reason for recall

Lack of Assurance of Sterility.

Distribution

Nationwide within USA

Key facts

Status
Terminated
Initiation date
2017-08-15
Report date
2017-09-20
Termination date
2018-04-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chicago, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1156-2017