FDA recall D-1180-2018

Westminster Pharmaceuticals LLC · Class I · drug

Product

Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-155-04.

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

Nationwide in the USA and Puerto Rico

Key facts

Status
Terminated
Initiation date
2018-08-03
Report date
2018-08-29
Termination date
2020-06-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Olive Branch, MS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1180-2018