FDA recall D-1157-2017
Bella Pharmaceuticals, Inc. · Class II · drug
Product
Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution, 15mL bottle, 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-1157-2017