FDA testing confirms inconsistent potency in the active ingredient

Update [9/5/2018] FDA is alerting active pharmaceutical ingredient (API) repackagers and distributors, finished drug manufacturers, and compounders that Sichuan Friendly Pharmaceutical Co. Limited, China, has recalled all unexpired lots of porcine thyroid API due to inconsistent quality. FDA recommends that companies check their supply and quarantine any API from Sichuan Friendly.

FDA reminds manufactures and compounders that Sichuan Friendly API may not be identified as the API manufacturer. The API may also be labeled as Sichuan Beisheng T, Sichuan Beisheng Trading, Sichuan Beisheng Technology or another API supplier.

[8/17/2018] 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.

However, FDA confirmed Sichuan Friendly’s thyroid API remains in the U.S. supply chain. 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. Therefore, manufacturers and compounders who make levothyroxine and liothyronine drug products should contact their API supplier to verify the actual manufacturer of the thyroid API they received before using it. Sichuan Friendly’s products may be labeled as “Thyroid Powder” or “Thyroid Powder USP.”  

Additionally, 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.

FDA recommends patients talk to their health care professional before they stop taking their combination levothyroxine and liothyronine thyroid medicine. FDA also recommends that patients discuss FDA-approved hypothyroidism treatment options with their doctors, as combination levothyroxine and liothyronine products are not FDA-approved.

FDA advises patients not to use porcine thyroid medicine labeled as Westminster

Additionally, on August 9, 2018, Westminster Pharmaceuticals LLC 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. FDA laboratory testing confirmed inconsistent levels of levothyroxine and liothyronine. Therefore, FDA recommends patients not use porcine thyroid drug products made by Westminster.

FDA inspection and adverse event reporting

FDA inspected the Sichuan Friendly’s facility in 2017 and discovered serious quality deficiencies, including:

• use of an incorrect formula to calculate the potency of the API, which means there may be inconsistent levels of levothyroxine and liothyronine present in the API, and
• multiple batches of API released with certificates of analysis containing inaccurate potency and stability data, and
• no stability data to support the claimed shelf-life of the API.

Health care professionals and patients are encouraged to report any adverse events associated with porcine thyroid medications to the FDA’s MedWatch Adverse Event Reporting program:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.

FDA will continue to provide additional information as it becomes available.

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.