Artificial Tears eye drops recalled due to lack of sterility assurance
Artificial Tears glycerin eye drops made by Preferred Pharmaceuticals are being recalled due to lack of sterility assurance. The 0.5 oz bottles were distributed nationwide.
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 recall for lack of sterility assurance. No illnesses or injuries reported; the hazard is potential rather than confirmed. Meets criteria for score 3: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Artificial Tears glycerin eye drops manufactured by Preferred Pharmaceuticals, Inc. are being recalled. The recalled product is a lubricant eye drop containing glycerin 0.2%, hypromellose 0.2%, and polyethylene glycol 400 1%, sold in 0.5 oz bottles.
The recall was initiated due to lack of assurance of sterility. Sterile conditions are essential for eye drops because the product is applied directly to the eye, a sensitive tissue.
The affected product was distributed nationwide. Consumers who have purchased this product with the affected lot numbers—F1924R, F2024G, F2424E, G2424M, G2624P, or J2424M—should stop using it and consult their healthcare provider. The product NDC is 68788-7266-0.
The recalled product
- Product
- ARTIFICIAL TEARS (GLYCERIN)
- Brand
- ARTIFICIAL TEARS
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- sterility-failure
- infection-risk
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 (6)
- Lot #: F1924R
- F2024G
- F2424E
- G2424M
- G2624P
- J2424M
Distribution
Distributed nationwide across the United States.
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