octiq Lubricating Eye Drops Recalled Due to Sterility Assurance Defect
Innovus Pharmaceuticals recalled octiq Lubricating Eye Drops due to lack of assurance of sterility. The affected lot was distributed to accounts in Rhode Island and Colorado.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II drug recall with no reported illnesses or injuries. The hazard of sterility failure in eye drops is a risk-of-harm product, but no actual harm has been reported, making this High severity rather than Severe.
Plain-English summary
octiq Lubricating Eye Drops (Dextran 70.01%, Hypromellose 0.3%) manufactured by Amman Pharmaceutical Industries for Innovus Pharmaceuticals is being recalled. The product consists of 2-bottle packs, 0.5 FL OZ each (15 mL bottles).
The recall was issued due to lack of assurance of sterility. Eye drops must maintain sterility to prevent infection and other complications when applied directly to the eye.
The recall affects lot YM308 (expiration 10/24), with 30,490 units distributed to two direct accounts in Rhode Island and Colorado.
Consumers who have purchased this product should discontinue use and contact their healthcare provider if they have experienced any eye irritation, infection, or other adverse effects.
The recalled product
- 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.
- Manufacturer
- AMMAN PHARMACEUTICAL INDUSTRIES
- Category
- Drug — Eye Drops
- Hazard
- sterility-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: YM308 EXP:10/24
Distribution
Distributed in 2 states:
- CO
- RI
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