Recalls / Class I

Class ID-1178-2018

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 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.

Affected lot / code info: 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.

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-1178-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.