Thyroid Medication Recall | RetailMeNot Rx Saver

A popular thyroid medication is being recalled, due concerns over its quality. Westminster Pharmaceuticals announced the recall, after one of its Chinese suppliers failed to meet FDA quality standards.

Levothyroxine / Liothyronine is under voluntary recall. The drug combination is made up of synthetic hormones and is used when the thyroid gland no longer functions properly.

What to do if you’re affected by the thyroid medication recall

As of August 9, there have been no adverse effects reported, related to the medication. The FDA recommends that consumers contact their physician or pharmacist for further guidance. The FDA’s website does say “Because these products may be used in the treatment of serious medical conditions, patients taking the recalled medicines should continue taking their medicine until they have a replacement product.”

Westminster Pharmaceuticals is recalling all lots of Levothyroxine / Liothyronine 15mg, 30mg, 60mg, 90mg, & 120mg, to the wholesale level. The recall is a precaution, related to the manufacturer using active pharmaceutical ingredients that were sourced prior to the FDA’s import alert of Sichuan Friendly Pharmaceutical Co., Ltd.

Why Levothyroxine / Liothyronine is being recalled

On June 22, 2018, the FDA sent a warning letter to Sichuan Friendly Pharmaceutical Co., Ltd., to inform them of the significant deviations from the FDA’s current good manufacturing process for active pharmaceutical ingredients (API).

The list of violations that initiated the recall

The letter to Sichuan Friendly Pharmaceutical Co., Ltd. specifically called out the following violations:

1. Failure to ensure that all specifications and test procedures are scientifically sound and appropriate to ensure that your API conform to established standards of quality and purity.

2. Failure to adequately validate written procedures for the cleaning and maintenance of equipment.

3. Failure to design a documented, on-going stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates.

4. Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and to have adequate controls to prevent omission of data.

An announcement on the FDA’s website says Westminster is notifying direct accounts by email and by phone to immediately discontinue distribution of the product being recalled.

Consumers with questions about the recall, or to report adverse effects, or other questions can contact Westminster’s Regulatory Affairs Department on weekdays at 888-354-9939 or email recalls@wprx.com.

You can read more about FDA recalls here.

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