The Food and Drug Administration (FDA) has announced that two thyroid medications are being voluntarily recalled because of a possible problem with an ingredient.
The medications are Levothyroxine and Liothyronine (Thyroid Tablets, USP) in 15-, 30-, 60-, 90- and 120-milligram tablets. Both medications are manufactured by Westminster Pharmaceuticals, LLC.
“These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Manufacturing Practices (cGMP),” reads a statement from the FDA. “Substandard cGMP practices could represent the possibility of risk being introduced into the manufacturing process.”
Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration https://t.co/YiIpUDbakf
— U.S. FDA (@FDArecalls) August 10, 2018
So far, Westminster has not received any reports of injury or illness related to the medications.
“They think that at this manufacturer in China that some impurities can go into the drug,” Scot Ackerman, the medical director of Ackerman Cancer Center, explained to News 4 Jax. “There have been no reports of any adverse events because of this, but this manufacturer has been known to have some impurities in their drugs, so the FDA has looked at that and said, ‘For now, to be safe, don’t use these.’”
Because these medications may be taken for the treatment of serious medical conditions, the FDA advises that patients prescribed these medications continue taking them as directed until there is a suitable replacement. If you believe you’re taking one of the affected products, you should contact your doctor for further guidance.
“You do want to take the thyroid medication daily,” Ackerman told News 4 Jax. “You don’t want to have any kind of gap.”
The products subject to recall are packed in 100-count bottles. The NDCs, product description, lot numbers and expiration dates for all of the products subject to recall can be found in the chart provided here. Distribution of the recalled products is being discontinued, and the affected products are being returned to Westminster.
Consumers who have questions or information about an adverse effect should contact Westminster’s Regulatory Affairs department at 888-354-9939 or [email protected].
Problems with the medications can also be reported to the FDA’s MedWatch Adverse Event Reporting program:
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA- 0178
Again, if you have questions about your own medication, call your doctor for further instruction.