Eye Lubricant Drops Recalled for Insufficient Sterility Assurance
Akorn, Inc. is recalling 62,331 boxes of TheraTears Extra lubricant eye drops distributed nationwide due to lack of assured sterility. Non-sterile eye drops could pose infection risks.
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 with no reported illnesses or injuries. The hazard—lack of sterility assurance for eye drops—represents a risk-of-harm situation for a sensitive product application, meeting the High (3) classification per the rubric.
Plain-English summary
Akorn, Inc. is recalling TheraTears Extra (sodium carboxymethylcellulose 0.25%) lubricant eye drops due to a lack of assured sterility. The recalled product consists of 30 sterile single-use vials per box. Approximately 62,331 boxes were distributed nationwide. The affected lots are 913012, 913013, and 913014, with an expiration date of 1/31/2023.
The recall was initiated because the manufacturer could not ensure that all units in the affected lots met required sterility standards. Non-sterile eye drops pose a potential risk of eye infection or other complications.
The product was distributed nationwide in the United States. Consumers with boxes matching the affected lot numbers should discontinue use. Anyone who has experienced adverse effects or has concerns about their eye health should consult a healthcare provider.
The recalled product
- Product
- THERATEARS EXTRA (CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED)
- Brand
- THERATEARS EXTRA
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- sterility-assurance-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 (4)
- Lot #: 913012
- 913013
- 913014
- Exp. Date 1/31/2023
Distribution
Distributed nationwide across the United States.
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