Recalls / Class I

Class ID-1181-2018

Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.

Affected lot / code info: 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.

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.

Recalling firm

Firm: Westminster Pharmaceuticals LLC
Notification channel: Letter
Type: Voluntary: Firm initiated
Address: 1 & 2, 154 Downing Street, Olive Branch, Mississippi 38654

Distribution

Quantity: Unknown
Distribution pattern: Nationwide in the USA and Puerto Rico

Timeline

Recall initiated: 2018-08-03
FDA classified: 2018-09-07
Posted by FDA: 2018-08-29
Terminated: 2020-06-03
Status: Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1181-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.