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: 0G75A, 0G12A, EXP 6/30/2023; 0H50A, EXP 7/31/2023; 0J88A, EXP 8/31/2023; 1D98A, EXP 3/31/2024; 1E31A, EXP 4/30/2024; 1D97A, EXP 3/31/2024; 1H14A, EXP 7/31/2024;
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Cromolyn: every company that makes it
- Form
- solution/ drops
- Strength
- 40 mg per 1 mL
- Approval
- ANDA ANDA074706
- On the market since
- Apr 29, 1998
- Package NDCs
17478-291-11- Official label
- DailyMed (National Library of Medicine), updated Jan 25, 2022
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?