The Recall Desk

FDA (Drugs) recall action 90037

Macleods Pharma Usa Inc recalled 6 products on 2022-05-11

The FDA (Drugs) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2022-05-11
Critical
0
Units
—

Why these products were recalled

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

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

1–6 of 6

  • HighFDA (Drugs)··2022-05-11

    Losartan potassium and hydrochlorothiazide tablets recalled for manufacturing quality deviations

    Macleods Pharma USA is recalling Losartan Potassium and Hydrochlorothiazide tablets due to manufacturing quality issues with chemical impurity levels above acceptable limits. Affected lots were distributed nationwide in 30-, 90-, and 1000-count bottles.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2022-05-11

    Losartan Potassium Tablets Recalled Due to AZIDO Impurity Above Limits

    Macleods Pharma USA Inc. is recalling Losartan Potassium 25 mg tablets due to higher-than-acceptable levels of AZIDO impurity from manufacturing deviations. The affected lots were distributed nationwide.

    Product
    LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2022-05-11

    Losartan Potassium and Hydrochlorothiazide Tablets Recalled for Manufacturing Defect

    Macleods Pharma USA Inc is recalling multiple lots of Losartan Potassium and Hydrochlorothiazide tablets (NDC# 33342-052-07, 33342-052-10, 33342-052-44) distributed nationwide due to AZIDO impurity levels exceeding acceptable limits.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-05-11

    Losartan Potassium and Hydrochlorothiazide Tablets Recalled Due to AZIDO Impurity Contamination

    Macleods Pharma USA is recalling Losartan Potassium and Hydrochlorothiazide tablets due to AZIDO impurity levels exceeding acceptable manufacturing standards. The prescription blood pressure medication was distributed nationwide.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2022-05-11

    Losartan Potassium Tablets Recalled for Excessive Azido Impurity

    Macleods Pharma is recalling Losartan Potassium Tablets due to CGMP deviations with azido impurity levels exceeding acceptable limits. The recall affects 5.6 million tablets distributed nationwide.

    Product
    LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Distribution
    0 states