Where it's 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 |
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
- May 1, 2012
- Package NDCs
61748-304-0161748-304-1161748-304-13- Official label
- DailyMed (National Library of Medicine), updated Dec 19, 2022
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?