US FDA issues an alert on life-threatening porcine therapy API
The active pharmaceutical ingredient (API) was recalled after inconsistent levels were found during US Food and Drug Administration (FDA) testing. On March 22nd of 2018, the Sichuan’s ingredient was put on import alert 66-40 after deviations were found during FDA inspection for good manufacturing practices.
The thyroid API, levothyroxine and liothyronine, is used to create a non-FDA approved drug for hypothyroidism – the product is created from porcine (pig thyroid gland). Inconsistent levels of the active ingredient in the API may cause “life-threatening adverse consequences” according to the FDA.
FDA urges manufacturers to contact their API supplier as this particular API may be repackaged or relabeled so as to not be identified as originally coming from Sichuan Friendly Pharma.
Inconsistent levels of the active ingredient should not be used to manufacture drugs for patient use and the FDA noted that Sichuan Friendly Pharma’s porcine thyroid API should not be used if it was received after August of 2015.
According to an FDA representative further information regarding the import alert is not currently available as it is an ongoing investigation.
However, “Manufacturers and compounders who have received API made by Sichuan Friendly should quarantine the API and associated drug products. If manufacturers and compounders have API or drug products made from Sichuan Friendly API, FDA requests these companies contact FDA’s regional offices,” said the representative.
