NDC 67046-083
Clindamycin hydrochloride 150 mg capsule
On the label: Coupler Enterprises Inc.. It's repackaged: Coupler Enterprises Inc. rebottles it from Caraco Pharmaceutical Laboratories, Ltd.'s NDC 63304-692.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Ohm Laboratories Inc. | North Brunswick, NJ, United States | Makes it | No problems foundOct 31, 2024 · 22 inspections |
| Sun Pharmaceutical Industries Limited | Halol, India | Makes it | Serious problems, FDA actionJun 13, 2025 · 12 inspections, 5 with FDA action |
Repackaging site
- Coupler Enterprises, Location not on file · repackages it
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots: AB77104
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
- Strength
- 150 mg
- Approval
- ANDA ANDA065061
- On the market since
- Sep 20, 2017
- Package NDCs
67046-083-0767046-083-1467046-083-1567046-083-2067046-083-2167046-083-2867046-083-3067046-083-60- Official label
- DailyMed (National Library of Medicine), updated Sep 20, 2017
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