Drug 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.
D-1178-2018
Product summary
- Event
- Event 80719
- Status
- Terminated
- Classification
- Class I
- Quantity
- Unknown
- Official record key
drug-enforcement:D-1178-2018
Official wording
Reason: 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.
Code information: 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.
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Manufacturing or process control
lack of process controls
-
Potency or specification failure
Failed Content Uniformity Specifications