PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: September 27, 2023 Initiated: September 1, 2023 #D-1167-2023

Product Description

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

Details

Units Affected
30,490 units
Distribution
Product was distributed to two (2) direct accounts in RI and CO.
Location
Amman

Frequently Asked Questions

What product was recalled?
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.. Recalled by AMMAN PHARMACEUTICAL INDUSTRIES. Units affected: 30,490 units.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on September 27, 2023. Severity: Moderate. Recall number: D-1167-2023.