BRIEF—FDA alerts drugmakers of a recall of porcine thyroid API from China

The US Food and Drug Administration is alerting active pharmaceutical ingredient (API) repackagers and distributors, finished drug manufacturers, and compounders that China-based Sichuan Friendly Pharmaceutical   is recalling certain lots of porcine thyroid API due to inconsistent quality of the API.

The FDA recommends that manufacturers and compounders not use Sichuan Friendly’s porcine thyroid API received since August 2015.

This thyroid API comes from porcine (pig) thyroid glands and is used to make a non-FDA approved drug product, composed of levothyroxine and liothyronine, to treat hypothyroidism (underactive thyroid).

FDA laboratory testing confirmed the Sichuan Friendly API has inconsistent levels of the active ingredients – levothyroxine and liothyronine – and should not be used to manufacture or compound drugs for patient use.

Risks associated with over or under treatment of hypothyroidism could result in permanent or life-threatening adverse health consequences.

This API and the drug products made from it, present a safety risk to patients.

Sichuan Friendly API may be repackaged and/or relabeled before it is further distributed, and not all of the repackaged/relabeled API identifies Sichuan Friendly as the original API manufacturer.

Additionally, manufacturers and compounders who have received API made by Sichuan Friendly should quarantine the API and associated drug products.

Additionally, on August 9, 2018, Westminster Pharmaceutical voluntarily recalled all unexpired lots of levothyroxine and liothyronine (thyroid tablets) 15mg, 30mg, 60mg, 90mg, and 120mg.

These products were made using API from Sichuan Friendly.