GlaxoSmithKline yanks Paxil batches after FDA warning letter

GlaxoSmithKline ($GSK) has its second recall in as many weeks on its hands, this time affecting batches of the antidepressant Paxil that contain an ingredient manufactured at an Irish plant the FDA says isn't up to snuff.

As RTÉ News reports, GSK said Wednesday it would pull 47 batches of the drug from wholesalers. The company maintains that the potentially tainted pills pose no risk to human health.

The recall follows a talking-to from the FDA: Tuesday, the agency lambasted the British drugmaker for deciding the issues raised about the plant in Cork, Ireland--specifically, a contamination risk to Paxil's active ingredient--didn't warrant any customer notice.

"We are concerned that your firm does not consider the entry of pharmaceutical waste streams into your manufacturing process a significant deviation with a potential quality impact," the regulator said in a warning letter posted on its website.

The FDA also blamed the company for failing to take sufficient action to clear up problems it identified during an October inspection. In addition to finding products made with solvents tainted by material from a "waste tank," it also expressed concerns about the suitability of the equipment used to manufacture the Paxil ingredient, RTÉ notes.

It has not been a good couple weeks for Glaxo as far as recalls go. Last week, the company reeled in all packages of its weight-loss drug alli and launched a product-tampering probe after some U.S. consumers said they found the wrong drugs in their bottles.

- get more from RTÉ
- read the warning letter

Special Report: The top 10 pharma companies by 2013 revenue - GSK

Suggested Articles

Turns out Procter & Gamble didn’t want Pfizer’s consumer health unit after all. But it did want Merck KGaA’s.

Private equity firm, in exclusive talks with Sanofi, says it'll invest to pump up Zentiva into an "independent European generics leader."

With suitor Takeda circling Shire, the Dublin-based target has pulled off a deal of its own.