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Public Alert No: 0019/2019 – Alert on Voluntary Recall of Xalatan* Eye Drops Lot Numbers W67369 and AK4753

 

November 3, 2019,

The National Agency for Food and Drug Administration and Control (NAFDAC) informs the public, especially health care providers that Pfizer Specialties Limited, 21 Lugard Avenue, Ikoyi Lagos  is executing a voluntary recall of Xalatan* (Latanoprost 0.005%) Eye Drops Lot Numbers W67369 and AK4753 from the Nigeria market.

The recall is due to detection of confirmed falsified Xalatan® 0.005% w/v Eye Drops 2.5 ml solution with authentic Pfizer Specialties Limited Lot Numbers W67369 and AK4753  detected in the legitimate supply chain in Nigeria.

The falsified Xalatan® 0.005% w/v Eye Drops 2.5 ml solution was detected following a market survey conducted by Pfizer Global Security on selected Pfizer products exposed to counterfeiting in the Nigerian market.

Pfizer Specialties Limited explained that the public, especially patients will not be able to differentiate between the genuine and falsified lots of Xalatan* Eye Drops. As a result of this, the company is executing a voluntary recall of Genuine Xalatan* Eye Drops with authentic Lot Numbers  W67369 and AK4753 from circulation in order to protect the patients.

The details of the affected lots of Xalatan® 0.005% w/v Eye Drops 2.5 ml solution are:

S/No. Product Lot No. Expiry Date NAFDAC REG. No.
1 Xalatan® 0.005% Eyedrop x 2.5ml W67369  

10/2020

 

04-4198

2 Xalatan® 0.005% Eyedrop x 2.5ml AK4753  

10/2021

 

04-4198

Genuine  Xalatan® 0.005% w/v Eye Drops 2.5 ml solution registered by NAFDAC is manufactured by Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870, Belgium. The genuine  Xalatan® 0.005% w/v Eye Drops is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

NAFDAC has strengthened surveillance at all ports of entry to prevent importation of falsified Xalatan® 0.005% w/v Eye Drops into Nigeria. The Agency has also heighten surveillance in all the States of the Federation and the Federal Capital Territory, Abuja to prevent the distribution and sale of the falsified  Xalatan® 0.005% w/v Eye Drops.

Distributors and wholesalers in possession of Xalatan* (Latanoprost 0.005%) Eye Drops Lot Numbers W67369 and AK4753 should immediately stop their distribution and sale.

Healthcare providers and members of the public with any information on  Xalatan* Eye Drops Lot Numbers W67369 and AK4753 should report such information to the nearest NAFADC office.

Patients should contact their physicians or healthcare providers if they experienced any problem that may be related to the use of this product.

Healthcare providers and consumers are encouraged to report adverse events associated with the use of medicines to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via pharmacovigilance@nafdac.gov.ng or via the eReporting platform available on the NAFDAC Website www.nafdac.gov.ng

NAFDAC…….. Customer-focused, Agency-minded!!!

Signed Management