NDC 12634-605
Atenolol 100 mg tablet
On the label: Apotheca, Inc.. It's repackaged: Apotheca, Inc. rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-024.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyAug 5, 2022 · 10 inspections, 3 with FDA action |
| Zydus Lifesciences Limited | Solan, India | Makes it and tests it | No problems foundMar 9, 2020 · 6 inspections |
Repackaging site
- Apotheca Inc., Phoenix, AZ, United States · repackages it and relabels it
Recalls
- Mar 6, 2017 · Class II · Zydus Pharmaceuticals USA Inc
Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
Lots: Lot #: a) Z600724, Exp 04/18; Z600725, Exp 04/18 - Aug 5, 2014 · Class II · Zydus Pharmaceuticals USA Inc
Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.
Lots: MP2292 Exp. 01/16
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Atenolol: every company that makes it
- Form
- tablet
- Strength
- 100 mg
- Approval
- ANDA ANDA076900
- On the market since
- Oct 8, 2005
- Package NDCs
12634-605-0012634-605-0112634-605-0912634-605-4012634-605-4212634-605-4512634-605-5012634-605-5212634-605-5412634-605-5712634-605-5812634-605-59- Official label
- DailyMed (National Library of Medicine), updated Jul 6, 2016
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