FDA Recall D-1181-2018

Westminster Pharmaceuticals LLC · Olive Branch, MS

Class I — life-threatening Terminated 670 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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.

Lot / code: 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.

Quantity: Unknown

Reason for recall

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.

Recall record

Recall number: D-1181-2018
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA and Puerto Rico
Recall initiated: 2018-08-03
Classified by FDA Center: 2018-09-07
FDA published: 2018-08-29
Terminated: 2020-06-03
Recalling firm: Westminster Pharmaceuticals LLC
Firm location: Olive Branch, MS

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