FDA is alerting active pharmaceutical ingredient (API) repackagers and distributors, finished drug manufacturers, and compounders that Sichuan Friendly Pharmaceutical Co. Limited, China, is recalling certain lots of porcine thyroid API due to inconsistent quality of the API. 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.
FDA placed Sichuan Friendly on import alert 66-40 on March 22, 2018, based on current good manufacturing practice (CGMP) deviations observed during an FDA inspection.
For more information:
- Sichuan Friendly Pharmaceutical Co. Limited warning letter, June 22, 2018
- See Guidance for Industry: ICHQ7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients for more information on how API, from original manufacturers as well as API repackagers and relabelers, should be labeled and clearly identify the original API manufacturer as the API moves through the supply chain.
