Sun Pharma’s 11-Eye-Drug Recall: What Doctors Found Before The Action

Sun Pharma’s decision to withdraw 11 ophthalmic products in July followed an alert from the All India Ophthalmological Society (AIOS) over possible bacterial contamination in certain batches of its Predmet eyedrops, according to a report by The Economic Times.

The AIOS, which represents nearly 27,000 eye specialists, informed its members on June 19 that multiple ophthalmic institutions had found contamination consistent with Pseudomonas species in some batches of the prescription medicine.

Predmet is used to treat a range of eye conditions, including redness and itching linked to allergies as well as more serious infections. Following the alert, Sun Pharma withdrew Predmet and on July 17 ordered a wider recall of 11 ophthalmic products as a precautionary measure.

What Did The Eye Specialists Flag?

The AIOS advised doctors to avoid using the quarantined batches until investigations were completed. It also called for greater vigilance among patients who may have been exposed to the products, particularly for conditions such as keratitis, postoperative infections, endophthalmitis and unexplained eye inflammation.

The society’s adverse events committee said similar microbiological characteristics had been found across multiple affected samples. These findings, it said, raised concerns about “a potential common-source contamination” and warranted immediate precautionary measures while investigations continued.

Pseudomonas bacteria are widely found in nature and can cause infections of varying severity. According to experts cited by ET, such infections can range from mild cases to serious ocular damage.

However, an ophthalmic surgeon told the publication that he had not, to date, identified any cases of endophthalmitis linked to the use of Predmet.

Why Did Sun Pharma Recall More Products?

The July 17 withdrawal covered 11 other ophthalmic products, including Depopred 2ML, Brinolar, Brizotim, Lotepred and Nepalact. Sun Pharma described the action as a “proactive voluntary withdrawal” taken as a matter of “abundant precaution.”

The company has not disclosed the affected manufacturing facility or details of the issue that led to the withdrawals. In an August 1 letter to medical experts, however, Sun Pharma said around 26 other ophthalmic products sold in India were “not manufactured from the affected facility.”

The company said those products were made either at qualified alternative Sun Pharma facilities or at independent external manufacturing sites. Products on the unaffected list included Cequa, Careprost LS, Gatilox DM, Timolet OD and Cafta.

Sun Pharma said it had put remedial measures in place, adding that “product quality and patient safety are important to us.”

India’s ophthalmic drugs market is worth around ₹4,721 crore and is growing at about 6% annually, according to PharmaTrac data cited by ET. The recall therefore comes against the backdrop of a large and growing eye-care medicines market.