NDC 71335-1126
Atorvastatin Calcium 40 mg tablet, film coated
On the label: Bryant Ranch Prepack. It's repackaged: Bryant Ranch Prepack rebottles it from Accord Healthcare Inc.'s NDC 16729-046.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | No problems foundJul 12, 2024 · 10 inspections |
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | Serious problems, FDA actionDec 2, 2022 · 7 inspections, 1 with FDA action |
Repackaging site
- Bryant Ranch Prepack, Burbank, CA, United States · repackages it and relabels it
Recalls
- Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a)R2100455, Exp. Date 3/31/2023; R2200274, Exp. Date 1/31/2024; R2200700, Exp. Date 5/31/2024; b) R2101342, R2101343, R2101476, Exp. Date 9/30/2023; R2101364, R2101365, R2101366, R2101367, Exp. Date 10/31/2023; R2101612, R2101613, R2101614, Exp. Date 11/30/2023; R2200222, R2200221, R22002… - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a)R2100305, Exp. Date 2/28/2023; R2200227, Exp. Date 1/31/2024; R2200797, Exp. Date 6/30/2024; b) R2101423, R2101438, R2101447, R2101446, Exp. Date 10/31/2023; R2200040, R2200041, R2200052, R2200043, R2200044, R2200051, R2200060, R2200061, R2200062, R2200077, R2200078, Exp. Date 12/31/202… - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a)R2100552, R2100553, Exp. Date 4/30/2023; R2200253, Exp. Date 2/29/2024; R2200627, Exp. Date 4/30/2024; R2201113, Exp. Date 6/30/2024; R2201184, Exp. Date 8/31/2024; R2201366, Exp. Date 9/30/2024; b) R2200280, Exp. Date 2/29/2024; R2200385, R2200386, R2200491, R2200490, R2200494, R220049… - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a)R2100283, R2100288, R2100289, Exp. Date 2/28/2023; R2200235, Exp. Date 1/31/2024; R2201037, R2200952, Exp. Date 6/30/2024; b) R2100291, R2100281, R2100282, R2100292, R2100293, R2100294, R2100290, R2100306, R2100348, R2100349, R2100347, R2100350, R2100356, R2100355, Exp. Date 2/28/2023; R…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Atorvastatin: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 40 mg
- Approval
- ANDA ANDA207687
- On the market since
- Aug 6, 2018
- Package NDCs
71335-1126-171335-1126-271335-1126-371335-1126-471335-1126-571335-1126-671335-1126-7- Official label
- DailyMed (National Library of Medicine), updated Oct 31, 2024
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