Posted from: Monday, September 17, 2018 - 12:19 PM - Present

Levothyroxine and Liothyronine Tablets and API Recalled

August 17, 2018 – The U.S. FDA has announced a recall of porcine thyroid (levothyroxine and liothyronine) active pharmaceutical ingredient (API) from Sichuan Friendly Pharmaceutical Co. Limited. The manufacturer is recalling the ingredient due to inconsistent quality. Four days prior, on August 13, 2018, Westminster Pharamceutical announced a voluntary recall of its levothyroxine and liothyronine combination tablets, which used Sichuan Friendly’s recalled API.

Levothyroxine and liothyronine combination tablets are generics for Allergan’s Armour® Thyroid and used to treat hypothyroidism. The recalled tablets come in 15mg, 30mg, 60mg, 90mg, and 120mg dosage strengths and were initially distributed in 100-count bottles.

The FDA cautions that drug manufacturers should not use porcine thyroid API produced by Sichuan Friendly dating as far back as 2015, due to concerns that Sichaun Friendly does not meet the standards for Current Good Manufacturing Practices. Patients currently on levothyroxine and liothyronine tablets should continue taking their medication until they have consulted with their physician.

BeneCard has determined that the recalled medication has not been dispensed from our mail service pharmacy. For patients who have questions regarding the recall, they are urged to speak directly to their physicians, or to contact Westminster’s Regulatory Affairs department by phone at 888-354-9939 or by email at recalls@wprx.com.

Consumers and healthcare professionals can also contact the FDA’s MedWatch program to report adverse events that may be related to the use of levothyroxine and liothyronine tablets.

A full list of affected products and their lot numbers is available at:

The above recalls do not affect products that contain levothyroxine only, such as Abbvie’s Synthroid® and its generics.

 

Last Updated Friday, October 19, 2018 - 01:32 AM.