The Recall Desk

FDA (Drugs) recall action 90127

RemedyRepack 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 HCTZ tablets recalled for manufacturing impurity levels above acceptable limits

    RemedyRepack Inc. is recalling Losartan HCTZ 100/12.5 mg tablets due to elevated AZIDO impurity levels exceeding acceptable manufacturing standards. The recall affects bottles distributed to Florida, South Carolina, and Virginia.

    Product
    Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
    Category
    Distribution
    3 states
  • HighFDA (Drugs)··2022-06-01

    Losartan HCTZ drug recall due to azido impurity levels above limits

    RemedyRepack Inc. is recalling Losartan HCTZ 100/25 mg tablets distributed in Florida, South Carolina, and Virginia due to azido impurity levels exceeding acceptable manufacturing limits.

    Product
    Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09
    Category
    Distribution
    3 states