NDC 54868-6366
Myorisan 40 mg capsule, liquid filled
On the label: Physicians Total Care, Inc.. It's repackaged: Physicians Total Care, Inc. rebottles it from Akorn's NDC 61748-304.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Douglas Manufacturing Limited | Lincoln Auckland, New Zealand | Makes it | Problems found, fixed voluntarilyMay 30, 2025 · 6 inspections |
| Swiss Caps AG | Kirchberg, Switzerland | Makes it | Problems found, fixed voluntarilyJun 29, 2023 · 6 inspections |
Repackaging site
- Physicians Total Care, Inc., Tulsa, Oklahoma, United States · relabels it
Recalls
- Jun 7, 2019 · Class III · Akorn Inc
Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
Lots: Lot#: V30M56A, Exp 9/20
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Isotretinoin: every company that makes it
- Form
- capsule, liquid filled
- Strength
- 40 mg
- Approval
- ANDA ANDA076485
- On the market since
- Aug 23, 2012
- Package NDCs
54868-6366-0- Official label
- DailyMed (National Library of Medicine), updated Jan 2, 2013
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