FDA Recall D-1180-2018
Westminster Pharmaceuticals LLC · Olive Branch, MS
Class I — life-threatening Terminated 670 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-1180-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall initiated
- 2018-08-03
- Classified by FDA Center
- 2018-09-07
- FDA published
- 2018-08-29
- Terminated
- 2020-06-03
- Recalling firm
- Westminster Pharmaceuticals LLC
- Firm location
- Olive Branch, MS