Recalls / Class I
Class ID-1179-2018
Product
Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-157-04.
- Affected lot / code info
- Lot #: 15717VP-01, 15717VP-02, 15717VP-03, Exp 7/31/2019; 15717002, Exp 12/31/2019; 15718004, Exp 3/31/2020.
Why it was recalled
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.
Recalling firm
- Firm
- Westminster Pharmaceuticals LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 & 2, 154 Downing Street, Olive Branch, Mississippi 38654
Distribution
- Quantity
- Unknown
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2018-08-03
- FDA classified
- 2018-09-07
- Posted by FDA
- 2018-08-29
- Terminated
- 2020-06-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1179-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.