Sun Pharma Recalls Subpotent Cequa Cyclosporine Ophthalmic Solution Vials
Sun Pharmaceutical Industries is recalling Lot 10007 of Cequa (cyclosporine) ophthalmic solution because the product is subpotent. The recall covers 37,400 cartons distributed nationwide and in Australia.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition indicates that use of the product is not likely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor issues.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is voluntarily recalling 37,400 cartons of Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials. The specific lot affected is Lot 10007, with an expiration date of 01/2022. The product is a prescription-only ophthalmic solution manufactured for Sun Pharma Global FZE by Laboratoire Unither in Coutances, France.
The recall was initiated because the product was found to be subpotent, meaning it may not contain the full labeled amount of the active ingredient. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
The affected product was distributed nationwide in the United States and in Australia. The recall was initiated on February 22, 2021, and was terminated on January 21, 2022. Consumers and healthcare providers should check their inventory for Lot 10007 and contact Sun Pharmaceutical Industries or their healthcare provider for further instructions.
The recalled product
- Product
- CEQUA (CYCLOSPORINE)
- Brand
- CEQUA
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Ophthalmic Solution
- Hazard
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 (2)
- Lot 10007
- exp. date 01/2022
Distribution
Distributed nationwide across the United States.
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