Geri-Care artificial tears lubricant eye drops recalled over sterility assurance
Preferred Pharmaceuticals is recalling six lots of Artificial Tears Lubricant Eye Drops manufactured by Geri-Care, citing lack of assurance of sterility. 720 bottles are affected.
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 of a sterile ophthalmic product where sterility cannot be assured, a risk of harm with no illnesses reported in the source.
Plain-English summary
Preferred Pharmaceuticals, Inc. is recalling Artificial Tears Lubricant Eye Drops containing glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%, in 0.5 oz bottles, manufactured by Geri-Care, NDC 68788-7266-0. The action covers 720 bottles.
The stated reason is lack of assurance of sterility. Ophthalmic products are required to be sterile because the eye has limited defences against introduced organisms. The FDA classified the action as Class II.
Affected lots are F1924R, F2024G, F2424E, G2424M, G2624P and J2424M. Distribution was nationwide within the United States.
Consumers and facilities holding an affected lot should stop using the product and contact the pharmacy or supplier from which it was obtained. Anyone who has used the drops and has concerns about their eyes should speak to a healthcare professional.
The recalled product
- Product
- ARTIFICIAL TEARS (GLYCERIN)
- Brand
- ARTIFICIAL TEARS
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic solution
- Affected units
- 720
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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