NDC 67046-1466
Losartan potassium 100 mg tablet, film coated
On the label: Coupler LLC. It's repackaged: Coupler LLC rebottles it from Macleods Pharmaceuticals Limited's NDC 33342-046.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Macleods Pharmaceuticals Limited | District Solan, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyOct 20, 2023 · 6 inspections, 2 with FDA action |
Repackaging site
- Coupler LLC, West Chester, PA, United States · repackages it
Recalls
- Apr 15, 2022 · Class II · Macleods Pharma Usa Inc
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots: Lot # BLH2002A, exp. date 11/2022 BLH2003B, exp. date 11/2022 BLH2004A, exp. date 11/2022 - Apr 15, 2022 · Class II · Macleods Pharma Usa Inc
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots: Lot # BLI2002A, exp. date 11/2022 BLI2004A, exp. date 11/2022 BLI2104B, exp. date 05/2023 - Apr 15, 2022 · Class II · Macleods Pharma Usa Inc
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots: Lot # BLI2107B, exp. date 06/2023 BLI2101A, exp. date 12/2022 BLI2103A, exp. date 12/2022 BLI2105A, exp. date 05/2023 - Jun 20, 2019 · Class II · Macleods Pharma Usa Inc
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Lots: BLI711A Nov 2019 - Jun 20, 2019 · Class II · Macleods Pharma Usa Inc
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Lots: BLI710A Nov 2019
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Losartan: every company that makes it
- Form
- tablet, film coated
- Strength
- 100 mg
- Approval
- ANDA ANDA202230
- On the market since
- Dec 6, 2024
- Package NDCs
67046-1466-3- Official label
- DailyMed (National Library of Medicine), updated Dec 6, 2024
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