NDC 67877-438
Minocycline Hydrochloride 105 mg tablet, film coated, extended release
On the label: Ascend Laboratories, LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alkem Laboratories Limited | Amaliya Daman, India | Makes it, tests it and packages it | No problems foundAug 30, 2019 · 6 inspections |
Recalls
- Jun 1, 2026 · Class II · Ascend Laboratories, LLC
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Lots: Lot# 25141635, Exp 4/30/2028 - Jan 22, 2020 · Class III · Ascend Laboratories LLC
Failed Dissolution Specifications: low out of specification results for dissolution testing.
Lots: Lot #: 19140414, Exp 12/2020
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Minocycline: every company that makes it
- Form
- tablet, film coated, extended release, oral
- Strength
- 105 mg
- Approval
- ANDA ANDA204453
- On the market since
- Sep 30, 2016
- Package NDCs
67877-438-0167877-438-0567877-438-1467877-438-30- Official label
- DailyMed (National Library of Medicine), updated Dec 18, 2025
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