The recall comes after the FDA issued an Import Alert concerning Sichuan Friendly Pharmaceutical Co., Ltd., which was found to have substandard manufacturing practices.
Westminster Pharmaceuticals, LLC. has issued a voluntary nationwide recall of all unexpired lots of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. Included in the recall are 5 national drug codes (NDCs) and 38 lot numbers.
“Westminster Pharmaceuticals aims to ensure that integrity is embedded in our reputation through the products we develop and market. We will never compromise when it comes to providing our patients with the caliber of medication they deserve. While we stand behind the quality of our product, we are taking the utmost precaution by recalling our Thyroid, USP Tablets only to the wholesale level due to a recent inspection by the FDA at one of our active ingredient manufacturers,” said Gajan Mahendiran, CEO of Westminster Pharmaceuticals.
The recall is a precautionary measure undertaken in response to a US Food and Drug Administration (FDA) Import Alert concerning Sichuan Friendly Pharmaceutical Co., Ltd. The Chinese company was found to have substandard Current Good Manufacturing Practices (cGMP) which could introduce risk into the manufacturing process.
As of August 9, 2018, Westminster Pharmaceuticals had not received any reports of adverse events related to thyroid tablets. Given the serious medical conditions that these tablets are designed to treat, patients taking the recalled products should continue to do so until they have a suitable replacement product.
The recall came after an FDA inspection of the Sichuan Friendly Pharmaceutical Company’s manufacturing facility in Neijiang, Sichuan, China from October 23 to 27, 2017 reported deviations from Current Good Manufacturing Practices for active pharmaceutical ingredients (API). The FDA placed the company on Import Alert beginning March 22, 2018.
“Until you correct all deviations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer,” reads the letter from Francis Godwin, Acting Director, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research.
The FDA warning letter included deviations such as issues with testing procedures, cleaning and maintenance of equipment, testing for storage and shelf life, and data access and accuracy.
Full information concerning the Levothyroxine and Liothyronine (Thyroid Tablets, USP) recalls, including national drug codes (NDCs), product description, lot numbers, and expiration dates, is available on the FDA website.