The Recall Desk

FDA (Drugs) recall action 90148

Preferred Pharmaceuticals, Inc. recalled 2 products on 2022-06-01

The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2022-06-01
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.

States named across these recalls

1–2 of 2

  • HighFDA (Drugs)··2022-06-01

    Losartan Potassium and HCTZ Tablets Recalled for AZIDO Impurity Deviations

    Preferred Pharmaceuticals is recalling specific lots of Losartan Potassium & HCTZ Tablets due to AZIDO impurity levels exceeding acceptable manufacturing standards. The recalled tablets were distributed in Florida and California.

    Product
    Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.
    Category
    Distribution
    2 states
  • HighFDA (Drugs)··2022-06-01

    Losartan Potassium and Hydrochlorothiazide Tablets Recalled for Elevated Azido Impurity

    Preferred Pharmaceuticals recalls Losartan Potassium & HCTZ Tablets (50mg/12.5mg) in Florida and California due to elevated azido impurity levels above acceptable manufacturing limits.

    Product
    Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09.
    Category
    Distribution
    2 states