FDA recall D-1167-2023

Product

octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus Pharmaceuticals, Inc., Englewood, CO 80112, Made in Jordan, NDC:57483-610-15.

Reason for recall

Lack of Assurance of Sterility

Distribution

Product was distributed to two (2) direct accounts in RI and CO.

Key facts

Status

Ongoing

Initiation date

2023-09-01

Report date

2023-09-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Amman, Jordan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1167-2023