Cequa cyclosporine ophthalmic solution recalled nationwide for subpotency
Sun Pharmaceutical is recalling Cequa (cyclosporine) ophthalmic solution because certain lots contain less active ingredient than specified. Contact your doctor if using an affected product.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is subpotency (insufficient active ingredient), which represents a manufacturing quality defect that compromises drug efficacy rather than creating direct safety harm. Class III recalls are typically rated 1-2.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling Cequa (cyclosporine ophthalmic solution) 0.09% due to subpotency. The FDA identified out-of-specification results showing that certain lots contain lower-than-specified levels of the active ingredient cyclosporine.
The affected product is Cequa 60 Single-Use Vials (6 pouches x 10 single-use vials, 0.25 mL each), NDC 47335-506-96. Affected lot numbers are 10026 and 10027, with expiration date 09/2023. Approximately 69,707 cartons were distributed nationwide in the United States.
Cequa is a prescription ophthalmic solution used to treat dry eye disease. If the medication contains less active ingredient than specified, it may not effectively treat the condition.
Patients currently using an affected lot should contact their healthcare provider immediately. Do not discontinue use without medical guidance, as abrupt cessation may affect treatment outcomes. Healthcare providers may recommend obtaining an unaffected product or alternative treatment.
The recalled product
- Product
- CEQUA (CYCLOSPORINE)
- Brand
- CEQUA
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Ophthalmic
- Hazard
- subpotency
- low-assay
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 (3)
- Lot# 10026
- Lot 10027
- Exp. 09/2023.
Distribution
Distributed nationwide across the United States.
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