D-1167-2023 Class II Ongoing

Recalled by AMMAN PHARMACEUTICAL INDUSTRIES — Amman

Recall Details

Product Type
Drugs
Report Date
September 27, 2023
Initiation Date
September 1, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
30,490 units

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

Distribution Pattern

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

Code Information

Lot: YM308 EXP:10/24;