Sun Pharma recalls six eye drop brands from the Indian market as ‘precautionary measure’
The company has not disclosed the reason for the withdrawal. In a communication to its distributors, the company said the recall was “a precautionary measure”.
Synopsis: Sun Pharma has withdrawn six prescription eye drop brands from the Indian market and asked distributors to stop billing the products and return existing stocks. The company has not disclosed the reason for the withdrawal. The medicines are widely prescribed after eye surgery, particularly cataract procedures, to treat pain and inflammation.
Sun Pharma, the Mumbai-based pharma giant, has withdrawn six prescription eye drop brands from the Indian market. The recalled products are Nepalact OD, Nepalact, Nepalact-Z, Lotepred T, Lotepred LS and Lotepred 1%.
The drugs are routinely prescribed after eye surgery, particularly cataract procedures, which are among the most commonly performed surgeries in the country.
In a communication to its distributors, the company said the recall was “a precautionary measure” and instructed them to immediately cease billing the medicines, share details of existing inventory, and return all available stock, including products sourced through other channels.
The company has not disclosed the reason for the withdrawal. Its communication to distributors does not specify whether the action stems from a quality issue, a manufacturing concern, a regulatory requirement or another reason.
South First emailed Sun Pharma a detailed questionnaire seeking clarification on the withdrawal. The company had not responded at the time of publication.
Nepafenac and loteprednol are prescription medicines that require medical supervision.
The Nepalact range is generally prescribed to control pain and inflammation after cataract surgery. It contains nepafenac, a non-steroidal anti-inflammatory drug (NSAID) formulated as an ophthalmic suspension.
“Patients usually begin using the drops a day before surgery and continue treatment for two to three weeks afterwards, depending on the surgeon’s advice,” an ophthalmologist told South First.
They added that nepafenac is also prescribed to prevent and treat macular oedema after cataract surgery, especially in patients with diabetes, who face a higher risk of the complication.
The Lotepred range contains loteprednol etabonate, a corticosteroid used to suppress inflammation after eye surgery and in several inflammatory eye disorders.
“Loteprednol is commonly used after cataract and refractive surgeries, as well as in conditions such as uveitis and allergic conjunctivitis. The drops are usually prescribed several times a day for one to two weeks after surgery, with the dosage gradually reduced as inflammation improves,” the ophthalmologist said.
Lotepred T, in particular, combines loteprednol with tobramycin, an antibiotic, allowing doctors to treat inflammation while also providing antibacterial cover where required.
The formulations differ in steroid strength. Lotepred LS contains a lower concentration suitable for milder inflammation, while Lotepred 1% is reserved for more severe cases, enabling ophthalmologists to tailor treatment to individual patients.
“Steroid eye drops such as loteprednol can increase intraocular pressure if used for prolonged periods. Because of this, ophthalmologists periodically monitor eye pressure during treatment to reduce the risk of complications such as glaucoma,” the ophthalmologist said.