may withhold approval of any new applications or supplements listing your firm as an API [active pharmaceutical ingredient] manufacturer.”
Paroxetine is an adult SSRI drug used for several forms of depression, panic, anxiety, obsessive-compulsive disorder, post-traumatic stress, some menopause-related symptoms, etc. GSK said in a statement:
“GSK acknowledges the concerns raised by the FDA and we are recommending a Class 3 recall ― that is a recall from wholesalers ― of certain batches of Paxil/Seroxat containing the paroxetine API supplied by the Cork site that are implicated in the Warning Letter. Based on a medical assessment, GSK considers that there is no increased risk of harm to patients taking finished product manufactured from the implicated batches of paroxetine API.” …The company added that it is currently “reviewing the content of the Warning Letter to assess the concerns raised, in order to develop appropriate Corrective and Preventative Actions. We will be able to comment further once we have prepared and submitted a comprehensive response to the Warning Letter to FDA by April 9.”
Two weeks earlier, Medscape reported GSK’s March 27 recall of “alli” its over-the-counterorlistat weight-loss drug, from U.S. and Puerto Rican retailers, due to customer complaints of bottles containing
“a range of tablets and capsules of various shapes and colors” [and some bottles] were missing labels and had tamper-evident seals that were not authentic. Orlistat is packaged in a labeled bottle that has an inner foil seal imprinted with the words, “Sealed for Your Protection.”
“We have received reports of about 20 bottles purchased by 12 consumers in 7 states: Alabama, Florida, Louisiana, Mississippi, New York, North Carolina, and Texas. We have had no reports of serious side effects,” Deborah Bolding, senior external communications manager, GSK Consumer Healthcare, told Medscape Medical News by email.
On March 26, GSK had issued a consumer alert for alli giving packaging lot numbers and expiration dates (see also Medscape article). The alli website was modified to prominently feature the recall warning, with slightly confusing-looking links to the company press release and to photos of the “authentic” product and the consumer alert.