Multiple batches of this popular drug recalled


AEMPS recalls batches of well-known eye drops used to treat conjunctivitis

Health Alert: Multiple batches of popular eye drops recalled due to reuse of filters. The Spanish Agency for Medicines and Healthcare Products (AEMPS) has announced the withdrawal from the market of three batches of eye drops used to treat eye symptoms. conjunctivitis Seasonal allergies. The reason is that quality defects were discovered during the manufacturing process of the product, which could compromise its sterility and lead to eye infections.

Health Reminder: Multiple batches of this popular eye drop have been recalled

this AEMPS Already ordered Withdrawal from the market of three lots of Ketobrill 0.25 mg/ml eye drops in single-dose containers, used to treat the ocular symptoms of seasonal allergic conjunctivitis.The reason for this action is that quality defects were detected during the manufacturing process of this product, including Sterile filter reuse This practice has not been proven.

According to AEMPS, the defect does not pose a life-threatening risk to patients, but may Compromising product sterility and cause eye infections. Users of this eye drop are therefore advised to check the batch number and expiry date on the packaging and, if it is one of the affected batches, return it to the pharmacy or point of sale where it was purchased.

Withdrawn plots

  • Batch: 21J004, valid until August 31, 2023.
  • Batch: 22C049, valid until February 28, 2024.
  • Batch: 22D022, valid until March 31, 2024.

These batches are produced by the company Pharma Stulln, The company is also the holder of the marketing authorization for the drug. AEMPS has classified the defect as Class 2, which means May have effects on the patient’s health, although not serious. The agency has urged the autonomous region to monitor the recall and require laboratories to take necessary corrective actions to prevent this problem from happening again.

AEMPS reminds health professionals and citizens that they can Report any suspected adverse reactions or for questions related to drug use through the Spanish Pharmacovigilance System or the spreadsheet available on its website.

This is Eye drops withdrawal case 2 Due to quality shortcomings so far this year. In February this year, AEMPS ordered the withdrawal of multiple batches of Oftacilox 3 mg/ml eye drop solution, used to treat bacterial eye infections because some of its units contain visible particles. In this case, the defect is classified as grade 1, the most severe type, as it may cause irreversible damage to vision.

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