The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) shared details of the class II recall (here in Japanese) on August 3.
According to the statement on the Agency’s site, the withdrawn Wypax tablets belong to batch #16G31A, which was distributed in Japan between April and June this year.
The US drug manufacturer confirmed the recall, telling us “Some tablets in this batch were found to have inconsistent embossing or engraving as compared with the approved Wypax product for Japan.”
A spokeswoman for the firm told us “We conducted an internal investigation and found there were no significant differences in the core tablet formulations other than the additional engraving on the Wypax tablet.
She added that: “We want to assure our patients and customers that there are no quality, safety or efficacy issues associated with this recall. Pfizer places the utmost emphasis on patient safety and product quality andhas voluntarily decided to recall the stated batch of Wypax tablets.
“The company has in place a rigorous quality system to ensure that materials are produced in accordance with all applicable Pfizer and regulatory standards.”