NDC 67046-2073
Clindamycin Hydrochloride 300 mg capsule
On the label: Coupler LLC. It's repackaged: Coupler LLC rebottles it from Glenmark Pharmaceuticals Inc., USA's NDC 68462-144.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Limited | Dhar, India | Makes it and tests it | Serious problems, FDA actionFeb 14, 2025 · 8 inspections, 1 with FDA action |
Repackaging site
- Coupler LLC, West Chester, PA, United States · repackages it
Recalls
- Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: Lot # 17241278, exp. date Jul-26 17241297, exp. date Jul-26 17241304, exp. date Jul-26 17241315, exp. date Jul-26 17241327, exp. date Jul-26
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Clindamycin: every company that makes it
- Form
- capsule, oral
- Strength
- 300 mg
- Approval
- ANDA ANDA216957
- On the market since
- Apr 29, 2026
- Package NDCs
67046-2073-3- Official label
- DailyMed (National Library of Medicine), updated Apr 29, 2026
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