NDC 53002-4643
Losartan Potassium 50 mg tablet, film coated
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Camber Pharmaceuticals Inc.'s NDC 31722-701.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hetero Labs Limited | Mahabubnagar, India | Makes it | Problems found, fixed voluntarilyAug 12, 2022 · 5 inspections, 1 with FDA action |
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · repackages it and relabels it
Recalls
- Feb 28, 2019 · Class II · Camber Pharmaceuticals Inc
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Lots: a) LOP17026B, LOP17050, LOP1705, LOP17052, LOP17053, Exp. Sep-19; LOP17061, Exp. Oct-19; LOP18035, LOP18036, Exp. Dec-19; b) LOP17026, Exp. Sep-19; c) LOP17006, Exp. May-19, LOP17025, Exp. Sep-19, LOP17068, Exp, Oct-19, LOP18037, LOP18038, LOP18039, Exp. Dec-19, LOP18057, Exp. Jan-20 - Feb 28, 2019 · Class II · Camber Pharmaceuticals Inc
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Lots: a) LOP17028C, Exp. Sep-19, LOP17064A, Exp. Nov-19; b) LOP17027, Exp Sep-19, LOP17063, LOP17093, Exp. Nov-19; LOP17094, LOP17095, LOP17097A, LOP17105, LOP17107, Exp. Dec-19; c) LOP17004, Exp Dec-19, LOP17028B, Exp Sep-19, LOP17048, LOP17049 Exp Oct-19, LOP17056, LOP17073, LOP17074, LOP17076 Ex… - Feb 28, 2019 · Class II · Camber Pharmaceuticals Inc
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Lots: a) LOP17011, Exp Aug-19, Lot LOP17087 Exp Nov-19; b) LOP17012, LOP17013, Exp Aug-19, LOP17042, LOP17043 Exp Oct-19, LOP17044, LOP17045, Exp Nov-19, LOP18024, LOP18025, LOP18026, LOP18027, LOP18028, LOP18029, LOP18030, Exp. Dec-19; c) LOP17005, Exp May-19, LOP17014, Exp Aug-19, LOP17016, L…
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
- 50 mg
- Approval
- ANDA ANDA203835
- On the market since
- Aug 19, 2015
- Package NDCs
53002-4643-353002-4643-9- Official label
- DailyMed (National Library of Medicine), updated Jun 7, 2023
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