A recent FiercePharma article discussed a massive Class III voluntary recall of Endo’s Gildess birth control. The recall began in September, but was only recently included in the FDA Enforcement Report. The tablets, a combination of norethindrone acetate and ethinyl estradiol, were manufactured in Ontario by Patheon and recalled for being subpotent.
This is the second recent recall of products manufactured by Patheon; in August, Actavis recalled 5 lots of Glipizide, a medication for Type 2 diabetes. However, the Glipizide issue was not related to manufacturing or packaging services rendered by Patheon. The dissolution of the product was traced back to an increase in bottle size and subsequent addition of a desiccant per Actavis’ request. The company reverted to the previous packaging configuration without the desiccant and promptly resumed production.
