D-1181-2018 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 29, 2018
- Initiation Date
- August 3, 2018
- Termination Date
- June 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Unknown
Product Description
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.
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.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
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.