NDC 53217-348
Rosuvastatin calcium 20 mg tablet, film coated
On the label: Aidarex Pharmaceuticals LLC. It's repackaged: Aidarex Pharmaceuticals LLC rebottles it from Accord Healthcare Inc.'s NDC 16729-286.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it | Serious problems, FDA actionDec 2, 2022 · 7 inspections, 1 with FDA action |
Repackaging site
- Aidarex Pharmaceuticals, Location not on file · repackages it
Recalls
- Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a) P2101063, Exp. Date 1/31/2024; P2101707, Exp. Date 2/29/2024; P2203913 Exp. Date 6/30/2025; b) P2101064, Exp. Date 1/31/2024; P2101539, Exp. Date 1/31/2024; P2101709, Exp. Date 2/29/2024; P2102138, Exp. Date 2/29/2024; P2103186, Exp. Date 5/31/2024; P2104430, Exp. Date 6/30/2024; P210… - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a) P2006824, Exp. Date 11/30/2023; P2102223, Exp. Date 3/31/2024; b) P2004949, Exp. Date 8/31/2023; P2004948, Exp. Date 8/31/2023; P2004950, Exp. Date 8/31/2023; P2004953, Exp. Date 8/31/2023; P2004954, Exp. Date 8/31/2023; P2004956, Exp. Date 8/31/2023; P2004955, Exp. Date 8/31/2023; P2… - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a) P2006560, Exp. Date 11/30/2023; P2101562, Exp. Date 2/28/2024; b) P2006561, Exp. Date 11/30/2023; P2006562, Exp. Date 11/30/2023; P2006587, Exp. Date 11/30/2023; P2100035, Exp. Date 11/30/2023; P2006600, Exp. Date 11/30/2023; P2006603, Exp. Date 11/30/2023; P2006604, Exp. Date 11/30/20… - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a) P2100343, Exp. Date 12/31/2023; P2102371, Exp. Date 3/31/2024; b) P2101966, Exp. Date 2/28/2024; P2104545, Exp. Date 6/30/2024; P2204500, Exp. Date 7/31/2025; P2205415, Exp. Date 8/31/2025; c) P2101591, Exp. Date 2/28/2023; P2200062, Exp. Date 12/31/2024; P2204336, Exp. Date 7/31/2025…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Rosuvastatin: every company that makes it
- Form
- tablet, film coated
- Strength
- 20 mg
- Approval
- ANDA ANDA206434
- On the market since
- Dec 7, 2017
- Package NDCs
53217-348-30- Official label
- DailyMed (National Library of Medicine), updated Aug 16, 2018
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