Levothyroxine and Liothyronine recalled over manufacturing violations

Recall date

August 3, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Westminster Pharmaceuticals LLC recalls Levothyroxine and Liothyronine (Thyroid Tablets, USP), 2 grain (120 mg), 100-count bottles, Rx Only, Manufactured for:…

Recall number

D-1182-2018

FDA classification

Class I

Brand / firm

Westminster Pharmaceuticals LLC

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Levothyroxine and Liothyronine (Thyroid Tablets, USP), 2 grain (120 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-158-04.