The Recall Desk

FDA (Drugs) recall action 80719

Westminster Pharmaceuticals LLC recalled 5 products on 2018-08-29

The FDA (Drugs) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2018-08-29
Critical
5
Units
—

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–5 of 5

  • CriticalFDA (Drugs)··2018-08-29

    FDA Recalls Levothyroxine and Liothyronine Tablets Due to Content Uniformity Failures

    Westminster Pharmaceuticals is recalling Levothyroxine and Liothyronine tablets because they failed content uniformity specifications due to an adulterated ingredient and poor manufacturing controls.

    Product
    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.
    Category
    Distribution
    1 state
  • CriticalFDA (Drugs)··2018-08-29

    FDA Recalls Levothyroxine and Liothyronine Thyroid Tablets Due to Content Uniformity Failures

    Westminster Pharmaceuticals is recalling specific lots of Levothyroxine and Liothyronine tablets because they failed content uniformity specifications due to an adulterated ingredient.

    Product
    Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-156-04.
    Category
    Distribution
    1 state
  • CriticalFDA (Drugs)··2018-08-29

    FDA Recalls Levothyroxine and Liothyronine Tablets Due to Content Uniformity Failures

    Westminster Pharmaceuticals is recalling Levothyroxine and Liothyronine tablets because they failed content uniformity specifications due to an adulterated ingredient and poor manufacturing controls.

    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.
    Category
    Distribution
    1 state
  • CriticalFDA (Drugs)··2018-08-29

    FDA Recalls Levothyroxine and Liothyronine Thyroid Tablets Due to Content Uniformity Failures

    Westminster Pharmaceuticals is recalling Levothyroxine and Liothyronine tablets because they failed content uniformity specifications, potentially resulting in incorrect drug strength.

    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.
    Category
    Distribution
    1 state
  • CriticalFDA (Drugs)··2018-08-29

    FDA Recalls Levothyroxine and Liothyronine Tablets Due to Content Uniformity Failures

    Westminster Pharmaceuticals is recalling Levothyroxine and Liothyronine tablets because they failed content uniformity specifications due to an adulterated ingredient and poor manufacturing controls.

    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.
    Category
    Distribution
    1 state