NDC 68084-291
Naltrexone Hydrochloride 50 mg tablet, film coated
On the label: American Health Packaging. It's repackaged: American Health Packaging rebottles it from SpecGx LLC's NDC 0406-1170.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| SpecGx LLC | Hobart, NY, United States | Makes it and tests it | No problems foundMar 13, 2020 · 6 inspections |
Repackaging site
- American Health Packaging, Columbus, OH, United States · repackages it
Recalls
- Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Naltrexone: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 50 mg
- Approval
- ANDA ANDA076264
- On the market since
- Jun 3, 2013
- Package NDCs
68084-291-1168084-291-21- Official label
- DailyMed (National Library of Medicine), updated Aug 5, 2024
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