The recall – detailed in the US Food and Drug Administration’s (FDA) latest enforcement report – covers 66 lots of the drug Gildess (ethinyl estradiol) that Patheon made for Endo’s Qualitest Pharmaceuticals unit.
The withdrawn pills were made at Patheon’s facility in Ontario, Canada.
A Patheon spokeswoman told us "Patheon is aware of the voluntary recall of certain lots of Gildess products due to a decreased level of ethinyl estradiol. We are currently working with our client to address the issue and cannot comment further at this time."
The recall – which is being managed by Endo’s Par Pharmaceutical business – is the second involving a product made by Patheon in recent months.
In August, generic drug firm Actavis pulled five lots of its diabetes pill glipizide after tests revealed the products did not meet label specifications.
However, as a Patheon's spokeswoman explained, the recall was related to a change in packaging and not any services provided by the CMO.
"A joint review of the product by the client and Patheon determined that the dissolution of the product was impacted by the increase in the bottle size and subsequent addition of a desiccant (drying agent inserted in the bottle) requested by the client. The issue was not related to the manufacturing or packaging services provided by Patheon.
She added that: "The client initiated a voluntary recall. The client switched back to the previous packaging configuration which does not require a desiccant and Patheon resumed production of the product in July."