Agency classClass IOur severity:Critical FDA (Drugs)·D-1182-2018·Announced 2018-08-29

FDA Recalls Levothyroxine and Liothyronine Thyroid Tablets Due to Content Uniformity Failures

Westminster Pharmaceuticals is recalling Levothyroxine and Liothyronine tablets because they failed content uniformity specifications, potentially resulting in incorrect drug strength.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class I recall for Levothyroxine and Liothyronine (Thyroid Tablets, USP), 2 grain (120 mg), 100-count bottles. The product is manufactured for Westminster Pharmaceuticals, LLC, and is available by prescription only. The recall covers specific lots: 15817VP-01, 15817VP-02, 15817VP-03 (Exp 9/30/2019) and 15818001 (Exp 3/31/2020).

The recall was initiated because the product was manufactured using an adulterated active pharmaceutical ingredient. Additionally, a lack of process controls and good manufacturing practices resulted in the finished product failing content uniformity specifications. This failure means the tablets may have a strength that is more or less than what is labeled on the bottle.

The affected products were distributed nationwide in the USA and Puerto Rico. Patients taking this medication should consult their healthcare provider for alternative treatment options and stop using the recalled product if advised by their provider.

The recalled product

Product: 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.
Manufacturer: Westminster Pharmaceuticals LLC
Category: Drug — Prescription Medication
Hazard: content-uniformity
adulterated-ingredient

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

Lot #: 15817VP-01
15817VP-02
15817VP-03
Exp 9/30/2019
15818001
Exp 3/31/2020.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Westminster Pharmaceuticals LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · Westminster Pharmaceuticals LLC

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Same hazard · content uniformity