Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Akorn | Location not on file | Makes it, tests it, packages it, labels it and sterilizes it | Not inspected on record |
Recalls
- Oct 13, 2022 · Class II · Akorn, Inc.
CGMP Deviations:
Lots: Lot: 0B55A, EXP 1/31/2023; 0D16A, 0D23A, EXP 3/31/2023; 0E51A, EXP 4/30/2023; 1C46A, EXP 2/29/2024;
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Hydroxyamphetamine and Tropicamide: every company that makes it
- Form
- solution
- Strength
- 10 mg per 1 mL / 2.5 mg per 1 mL
- Approval
- NDA NDA019261
- On the market since
- Jan 30, 1992
- Package NDCs
17478-704-12- Official label
- DailyMed (National Library of Medicine), updated Sep 14, 2022
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?