Thyroid medications with ingredients from Sichuan Friendly Pharmaceutical recalled
Recall includes porcine thyroid ingredients, Westminster Pharmaceutical products
Several thyroid medications manufactured with active pharmaceutical ingredients (APIs) produced by Chinese supplier Sichuan Friendly Pharmaceutical Co., Ltd. have been recalled after FDA found deficiencies in Sichuan Friendly’s manufacturing processes and inconsistent quality in the ingredients. FDA had previously included Sichuan Friendly on an in March after inspections revealed deviations from current good manufacturing practice.
On August 7, Westminster Pharmaceuticals recalled all unexpired lots of levothyroxine and liothyronine (Thyroid Tablets) 15 mg, 30 mg, 60 mg, 90 mg, and 120 mg to the wholesale level because they were manufactured using active pharmaceutical ingredients that were sourced prior to FDA’s import alert about Sichuan Friendly. FDA has published of the product’s names, lots, and expiration dates, and noted that these products are all packaged in 100-count bottles.
On August 17, FDA recommended that manufacturers and compounders not use any Sichuan Friendly’s porcine thyroid API they may have received since August 2015. This ingredient is made from pig thyroid glands to make products for treating hypothyroidism that are not FDA-approved.
FDA recommends that all manufacturers and compounders who make levothyroxine and liothyronine drug products their API supplier to verify who manufactured their thyroid API.