A reasonable chance it could cause serious harm or death.
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.
| Distributed by / for | Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654 |
| NDC | 69367-158-04 |
| Full product label | Levothyroxine and Liothyronine (Thyroid Tablets, USP), 2 grain (120 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-158-04. |
| Recalling firm | Westminster Pharmaceuticals LLC |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | Unknown |
| Recall initiated | 2018-08-03 |
| Report date | 2018-08-29 |
| Recall completed | 2020-06-03 |
| Recall number | D-1182-2018 |
| Classification | Class I |
| FDA status | Terminated |
| Origin on file | Olive Branch MS United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗