FDA recall D-912-2013

Earthlabs, Inc. DBA Wise Woman Herbals · Class II · drug

Product

Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and distributed by: Wise Woman Herbals, Creswell, OR

Reason for recall

Lack of Assurance of Sterility; Lack of Assurance of Sterility; product not manufactured under sterile conditions as required for ophthalmic drug products

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-05-27
Report date: 2013-08-28
Termination date: 2013-11-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Creswell, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-912-2013