NDC 53002-4322
tramadol hydrochloride 50 mg tablet
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Caraco Pharmaceutical Laboratories, Ltd.'s NDC 57664-377.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | Dadra, India | Makes it | Problems found, fixed voluntarilyMar 29, 2019 · 5 inspections |
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · repackages it and relabels it
Recalls
- Nov 5, 2012 · Class II · Caraco Pharmaceutical Laboratories, Ltd.
Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg.
Lots: Lot # GKK1373, Exp 09/13
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Tramadol: every company that makes it
- Form
- tablet
- Strength
- 50 mg
- Approval
- ANDA ANDA075964
- On the market since
- Jun 22, 2002
- Package NDCs
53002-4322-153002-4322-253002-4322-3- Official label
- DailyMed (National Library of Medicine), updated Mar 30, 2022
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