FDA recall D-474-2013
Nora Apothecary and Alternative Therapies, Inc. · Class II · drug
Product
PHMB Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration,
Reason for recall
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2013-04-22
- Report date
- 2013-06-05
- Termination date
- 2014-08-01
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Indianapolis, IN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-474-2013