NDC 54868-6378
Myorisan 20 mg capsule, liquid filled
On the label: Physicians Total Care, Inc.. It's repackaged: Physicians Total Care, Inc. rebottles it from Akorn's NDC 61748-302.
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
- Nov 15, 2019 · Class II · Akorn, Inc.
Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product.
Lots: Lot V20M54A, Exp 01/2021
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
- 20 mg
- Approval
- ANDA ANDA076485
- On the market since
- Oct 29, 2012
- Package NDCs
54868-6378-0- Official label
- DailyMed (National Library of Medicine), updated Jan 2, 2013
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