NDC 50090-5338
LOSARTAN POTASSIUM100 mg 100 mg tablet, film coated
On the label: A-S Medication Solutions. It's repackaged: A-S Medication Solutions rebottles it from Strides Pharma Science Limited's NDC 64380-935.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Strides Pharma Science Limited | Chengalpattu, India | Makes it, tests it and packages it | Problems found, fixed voluntarilyApr 5, 2024 · 7 inspections |
Repackaging site
- A-S Medication Solutions LLC, Libertyville, IL, United States · repackages it and relabels it
Recalls
- Jun 26, 2023 · Class II · Strides Pharma Inc.
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Lots: Lot#: 7901903A, exp. date 04/2024 - May 18, 2022 · Class II · Strides Pharma Inc.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots: NDC 64380-933-05 Lot 7901007A, Exp Date Jun-22; Lot 7901144A, 7901178A & 7901179A, Exp Date Sep-22; Lots 7901246A & 7901247A, Exp Date Oct-22; Lot 7901343A, Exp Date Dec-22. NDC 64380-933-08 Lot 7901006A, Exp Date Jun-22; Lot 7901145A & 7901180A, Exp Date Sep-22; Lot 7901181A, Exp Date Oct-22. - May 18, 2022 · Class II · Strides Pharma Inc.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots: NDC 64380-934-05 Lot 7901146A, 7901147A, 7901148A & 7901149A, Exp Date Sep-22; Lot 7901279A, 7901280A, 7901281A, 7901282A, 7901283A & 7901284A, Exp Date Nov-22; Lot 7901359A, 7901360A & 7901361A, Exp Date Dec-22; Lot 7901362A, 7901406A, 7901407A, 7901408A & 7901409A, Exp Date Jan-23. 64380-934-0… - May 18, 2022 · Class II · Strides Pharma Inc.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots: 64380-935-05 Lots 7901047B, 7901048B, 7901049B & 7901050B, Exp Date Jul-22; Lots 7901185A, 7901186A, 7901187A & 7901188A, Exp Date Oct-22; Lots 7901250A, 7901251A & 7901252A, Exp Date Nov-22. 64380-935-08 Lots 7900813B, 7900814B, 7900908A, 7900935A, 7900936A, 7900937A, 7900938A & 7900939…
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 ANDA090382
- On the market since
- Oct 9, 2019
- Package NDCs
50090-5338-0- Official label
- DailyMed (National Library of Medicine), updated Mar 2, 2021
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