According to the letter, the affected products are Depopred2ML, Brinolar (BKC FREE), Brinzotim Eye Drops 5ML BKC FREE, Lotepred-5ML, Lotepred 1% Eye Drops SML, Lotepred LS 0.2% E/D 5ML, Lotepred T, Nepalact OD Eye Drops 3ML, Nepalact-Z, Toba-F and Nepalact E/D 5ML.
In the letter, the company said, "Sun Pharma Distributors Ltd has decided, as a precautionary measure, to discontinue further distribution [of], and withdraw all existing stocks of the above products available in your channel."
The company also asked distributors to stop billing the affected products immediately and share details of any stock they still have. The letter states, "In this regard, you are requested to immediately cease billing of the above-mentioned product and provide us details of any stock currently held by you."
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It also asked distributors to return all available stock at the earliest. The letter added, "Further, you are requested to send back to us any stocks of the product available with you as well as those received from any sources on priority."
Responding to ANI, a Sun Pharma spokesperson said, "Patient safety remains our highest priority. We have taken all necessary steps in the best interest of patients and in accordance with applicable regulatory requirements. Our teams are working diligently to restore the availability of these products so that patients continue to have access to these treatment options."
An eye care expert said many of the recalled products are prescribed for patients recovering from eye surgery or treating long-term eye conditions such as glaucoma, eye infections, allergies and eye inflammation. "Many of these eye drops are prescribed for patients recovering from eye surgery or managing chronic conditions such as glaucoma, eye infections, allergies, and ocular inflammation, where interruption of treatment can have significant consequences," the expert said.
The expert also stressed the importance of maintaining sterility during manufacturing. "In a country like India, where millions rely on eye drops every day, maintaining sterility during manufacturing is non-negotiable. Even suspected contamination at a manufacturing facility can pose a serious risk to patient safety, making immediate product recalls essential," the expert said.
The expert advised patients not to stop using the recalled eye drops on their own. "Patients should not continue using a recalled product or discontinue treatment on their own, but should contact their ophthalmologist promptly so that an appropriate alternative can be prescribed, ensuring continuity of care while safeguarding vision," the expert said.