FDA Recalls Levothyroxine and Liothyronine Tablets Due to Content Uniformity Failures
Westminster Pharmaceuticals is recalling Levothyroxine and Liothyronine tablets because they failed content uniformity specifications due to an adulterated ingredient and poor manufacturing controls.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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), 1/4 grain (15 mg), 100-count bottles. The product is manufactured for Westminster Pharmaceuticals, LLC, and is available by prescription only. The recall covers specific lots with expiration dates ranging from October 31, 2019, to March 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 contain 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 who have been prescribed this medication should contact their healthcare provider for guidance on alternative treatments or further instructions regarding the recalled product.
The recalled product
- Product
- Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/4 grain (15 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-159-04.
- Manufacturer
- Westminster Pharmaceuticals LLC
- Category
- Drug — Prescription Medication
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 (17)
- Lot #: 15917VP03
- 15917VP02
- 15917VP01
- Exp 10/31/2019
- 15918004
- 15918003
- 15918002
- 15918001
- Exp 12/31/2019
- 15918VP03
- 15918VP02
- 15918VP01
- 15918005
- Exp 2/29/2020
- 15918007
- 15918006
- Exp 3/31/2020.
Distribution
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.
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