Pfizer is recalling batches of its Xalatan eye drop product, used to treat glaucoma, after encountering counterfeits in the marketplace with currently-valid lot numbers.
The company has said it has launched a patient-level recall of Xalatan 0.005% w/v eye drops (latanoprost), a $300m product that has been a mainstay of treatment for the sight-robbing disease for many years.
“The cause of this voluntary recall is due to the identification of two separate confirmed counterfeit Xalatan 0.005% w/v eye drops 2.5ml solution lots, with authentic Pfizer lot numbers W6769 and AK4753,” said Pfizer in a communication to healthcare providers.
The falsified product “was being distributed in the legitimate supply chain in the Nigeria market where the authentic Xalatan 0.005% w/v Eye drops 2.5ml solution with the same lot numbers been distributed,” it continued.
“The use of the counterfeit product lots has a high probability to cause therapeutic failure and adverse events, such as infections. The potential risk to patients is considered high as patients will not be able to identify the counterfeit product,” according to the company.
The fakes with the W67369 lot number have the expiry date of 10/2020, while the AK4753 lot says it expires 10/2021.
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