NDC 12634-771
Metoprolol Tartrate 50 mg tablet, film coated
On the label: Apotheca, Inc.. It's repackaged: Apotheca, Inc. rebottles it from Aurobindo Pharma Limited's NDC 65862-063.
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 |
| Aurolife Pharma LLC | Dayton, NJ, United States | Makes it and tests it | Serious problems, FDA actionDec 7, 2021 · 10 inspections, 1 with FDA action |
Repackaging site
- Apotheca Inc., Phoenix, AZ, United States · repackages it and relabels it
Recalls
- Sep 9, 2021 · Class II · Aurobindo Pharma USA Inc.
Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
Lots: Lot: MJ1019025-A, Exp. date 04/2022
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Metoprolol: every company that makes it
- Form
- tablet, film coated
- Strength
- 50 mg
- Approval
- ANDA ANDA077739
- On the market since
- Sep 11, 2007
- Package NDCs
12634-771-0012634-771-0112634-771-0912634-771-1212634-771-1812634-771-4012634-771-4212634-771-4512634-771-5012634-771-5212634-771-5412634-771-57- Official label
- DailyMed (National Library of Medicine), updated Jan 19, 2017
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