NDC 67046-1259
Simvastatin 5 mg tablet, film coated
On the label: Coupler LLC. It's repackaged: Coupler LLC rebottles it from Aurobindo Pharma Limited's NDC 65862-050.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited | Medchal, India | Makes it and tests it | Problems found, fixed voluntarilyJul 21, 2023 · 13 inspections, 1 with FDA action |
| Aurobindo Pharma Limited | Mahabubnagar, India | Makes it and tests it | Problems found, fixed voluntarilyMay 10, 2022 · 7 inspections, 1 with FDA action |
| Aurolife Pharma LLC | Dayton, NJ, United States | Makes it and tests it | Serious problems, FDA actionDec 7, 2021 · 10 inspections, 1 with FDA action |
| Aurovitas Pharma Taizhou Co.,LTD | Taizhou, China | Makes it and tests it | Not inspected on record |
Repackaging site
- Coupler LLC, West Chester, PA, United States · repackages it
Recalls
- Mar 18, 2020 · Class II · Aurobindo Pharma USA Inc.
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Lots: Lot #: 05319004A1, Exp. Date 03/2022 - Jul 29, 2019 · Class III · Aurobindo Pharma USA Inc.
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Lots: 05318054B, exp 3/2021
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Simvastatin: every company that makes it
- Form
- tablet, film coated
- Strength
- 5 mg
- Approval
- ANDA ANDA077691
- On the market since
- Nov 12, 2024
- Package NDCs
67046-1259-3- Official label
- DailyMed (National Library of Medicine), updated Nov 12, 2024
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