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Recall Observatory FDA recall evidence

Drug product

Levothyroxine and Liothyronine (Thyroid Tablets, USP), 2 grain (120 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-158-04.

D-1182-2018

August 03, 2018

Class I

Product summary

Firm
Westminster Pharmaceuticals LLC
Event
Event 80719
Status
Terminated
Classification
Class I
Quantity
Unknown
Official record key
drug-enforcement:D-1182-2018

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 #: 15817VP-01, 15817VP-02, 15817VP-03, Exp 9/30/2019; 15818001, Exp 3/31/2020.

Distribution pattern: Nationwide in the USA and Puerto Rico

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    lack of process controls
  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Content Uniformity Specifications