Public Alert No: 0022/2018 – Recall Of Latanoprost/Timolol 50mg/Ml+ 5mg/Ml Eye Drop Solution Due To Product Defect
August 10, 2018,
The National Agency for Food and Drug Administration and Control has been notified that the Hungarian Institute of Pharmacy and Nutrition (OGYEI) on the 9th May, 2018 recalled Latanoprost/Timolol 50mg/ml + 5ml/ml eye drop. The recall was due to the discovery of an unknown impurity during stability testing (EL (18) A/08).
Latanoprost/Timolol is used in reducing the pressure in the eye as a result of an open angle glaucoma or ocular hypertension. Both conditions are linked to an increase in the pressure within the eye which affects eyesight. The use of the affected product can result to hazardous effect on the eye.
The details of the affected product are:
Product Name: Latanoprost/Timolol 50mg/ml + 5mg/ml eye drop solution
Product Manufacture: FDC Pharma Ltd, Mumbia, India
Batch Number: 087B087
Expiry Date: January, 2019
NAFDAC implores healthcare providers and the general public to be vigilant and avoid the use of the affected batch of the product. Healthcare providers and consumers in possession of the affected batch of the product should submit them to the nearest NAFDAC office.
Report adverse event relating to the use of the affected product to the nearest NAFDAC office, NAFDAC PRASCOR (Toll free 20543 from all network) or via email@example.com.
NAFDAC…………. Safeguarding the Health of the Nation!!!