Sun Pharma Recalls 11 Eye Drop Products Across 10 Brands in India

Sun Pharma has voluntarily recalled 11 ophthalmic products across 10 eye drop brands from the Indian market as a precautionary measure, directing distributors to stop further distribution, cease billing, and return all existing stock. The Sun Pharma eye drops recall is among the most significant instances of eye drops recalled in India this year.

Several media reports have linked the recall to possible contamination concerns. However, Sun Pharma has not publicly disclosed the specific reason for the withdrawal, stating only that the move was made as a precautionary measure.

In a confidential letter dated July 17, accessed by ANI, Sun Pharma Distributors Ltd instructed distributors to immediately discontinue distribution of the affected products, stop billing them, and return all available stock on priority.

The recalled ophthalmic products are:

• Depopred 2 ml

• Brinolar (BKC Free)

• Brinzotim Eye Drops 5 ml (BKC Free)

• Lotepred 5 ml

• Lotepred 1% Eye Drops

• Lotepred LS 0.2% Eye Drops

• Lotepred T

• Nepalact OD Eye Drops 3 ml

• Nepalact-Z

• Toba-F

• Nepalact Eye Drops 5 ml

According to the distributor communication, the company decided, "as a precautionary measure," to discontinue further distribution and withdraw all existing stocks. Distributors were also instructed to immediately stop billing the products, provide inventory details, and return any available stock.

Also see: Eye Drops Replacing Reading Glasses Set for Indian Market Launch by October

Nepalact (Nepafenac)

According to the Australian Prescriber review, Nepafenac (2017), the Nepalact range contains nepafenac, a non-steroidal anti-inflammatory drug (NSAID) commonly prescribed to relieve pain and inflammation after cataract surgery. The medication is usually started around the time of surgery and continued during recovery. The review also notes that nepafenac may help lower the risk of postoperative macular oedema, particularly in people with diabetes undergoing cataract surgery. ²

Lotepred (Loteprednol)

According to the review Loteprednol Etabonate Ophthalmic Suspension 0.5%: Efficacy and Safety for Postoperative Anti-Inflammatory use, the Lotepred range contains loteprednol etabonate, a corticosteroid widely used to reduce inflammation and pain after eye surgery and to treat inflammatory eye conditions such as allergic conjunctivitis and anterior uveitis. Some formulations, such as Lotepred T, also contain the antibiotic tobramycin, offering protection against bacterial infections while reducing inflammation. ¹

Also see: Massive Eye Drop Recall Reflects Ongoing Issues with Manufacturing and FDA Inspection

Several media reports have reported that the recall followed possible contamination concerns. However, Sun Pharma has not publicly confirmed the nature of the issue, and its communication to distributors does not specify whether the withdrawal is related to a manufacturing issue, quality concern, regulatory requirement, or another reason.

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."

References:

1. Amon, Michael, and Massimo Busin. 2012. “Loteprednol Etabonate Ophthalmic Suspension 0.5%: Efficacy and Safety for Postoperative Anti-Inflammatory Use.” International Ophthalmology 32 (5): 507–517 https://pmc.ncbi.nlm.nih.gov/articles/PMC3459083/

2. Australian Prescriber. “Nepafenac.” Australian Prescriber 40, no. 6 (2017): 246–247. https://pmc.ncbi.nlm.nih.gov/articles/PMC5768593/?

(Rh/ARC/MSM)