Akorn, Inc. is recalling approximately 25,843 bottles of Eye Itch Relief (Ketotifen Fumarate) Ophthalmic Solution 0.035% because of deviations from Current Good Manufacturing Practice (CGMP) standards. This product is a sterile eye drop sold in 5 mL bottles under the CVS Pharmacy brand. Consumers should be aware that manufacturing deviations in sterile products can compromise the quality and safety of the medication.
The recall is due to manufacturing process deviations that do not meet sterile drug standards, which could potentially lead to product contamination or loss of efficacy. While no specific injuries have been reported, using a compromised ophthalmic solution can pose a risk of eye irritation or infection.
Drug product return and healthcare consultation.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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