FDA recall D-1049-2018

Longbow First Aid Products Manufactory · Class II · drug

Product

Eyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (NDC 6910-3218-07) and b) 8 Fl OZ (NDC 6910-3218-08) bottles, 77656 Flora Rd, Palm Desert, CA 92211.

Reason for recall

CGMP Deviations

Distribution

NY and CA.

Key facts

Status
Terminated
Initiation date
2018-07-17
Report date
2018-08-15
Termination date
2019-09-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Foshan, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1049-2018