Endo, which has already been dealing with “previously unanticipated headwinds,” has undertaken a massive recall of subpotent birth control pills manufactured for it by a contractor.
According to the most recent FDA Enforcement Report, the company is recalling 162 lots, comprising 1,365,559 tablets, of its Gildess in different dose sizes. The tablets were manufactured for Endo’s Qualitest Pharmaceuticals unit by Patheon at a plant in Ontario, Canada, the report says. The pills are a combination of norethindrone acetate and ethinyl estradiol and are being recalled for being subpotent for ethinyl estradiol, the report says.
The Class III voluntary recall, which began in September but was only recently posted by the FDA, is being handled by Endo’s Par Pharmaceutical unit.
Endo ($ENDP) slashed its 2016 revenue and earnings guidance in May after a disappointing quarterly performance. At the same time the company announced restructuring that called for eliminating 740 jobs at manufacturing sites, with plans to close a site in Charlotte, NC, and reduce employees at a facility in Huntsville, AL, both former Qualitest sites. But the birth control pills in this case were manufactured by CMO Patheon at its site in Ontario.
It is the second recent recall that a company has had to make of products manufactured by Patheon. In August, Actavis recalled five lots, consisting of 167,152 bottles, of Glipizide, a treatment for Type 2 diabetes. Those were manufactured by Patheon at a plant in Ohio, the report indicated.
A Patheon spokesperson said in that case, a joint review of the product by Actavis and Patheon determined that the dissolution of the product was impacted by the increase in the bottle size and subsequent addition of a drying agent inserted in the bottle that Actavis wanted. The issue was not related to the manufacturing or packaging services provided by Patheon, she said. Actavis switched back to the previous packaging configuration without a desiccant and Patheon resumed production of the product in July.
Editor's Note: The story was updated to reflect a fifth recall involving additional lots and with comments from Patheon.