FDA Recall D-1178-2018

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 grain (60 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-156-04.

Lot / code: Lot #: 15617VP03, 15617VP01, 15617VP-02, Exp 7/31/2019; 15617VP06, 15617VP05, Exp 11/30/2019; 15617VP04, 15618004, 15618002, Exp 12/31/2019; 15618009, 15618008, Exp 2/29/2020; 15618011, 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-1178-2018
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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