FDA (Drugs) recall action 90037
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.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
The agency’s own wording, quoted from the enforcement report.
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.
Macleods Pharma USA is recalling Losartan Potassium 50 mg tablets nationwide due to CGMP deviations with AZIDO impurity levels above acceptable limits. Affected lots: BLI2002A, BLI2004A, and BLI2104B.
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.
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.
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.
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.