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D-1167-2023Class II

AMMAN PHARMACEUTICAL INDUSTRIES

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
AMMAN PHARMACEUTICAL INDUSTRIES
Product type
Drug
Status
Ongoing
Report date
2023-09-27
Distribution
Product was distributed to two (2) direct accounts in RI and CO.
Product quantity
30,490 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

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.

Code / lot info

Lot: YM308 EXP:10/24;

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →