NDC 21695-530
Proparacaine Hydrochloride 5 mg per 1 mL solution
On the label: Rebel Distributors Corp... It's repackaged: Rebel Distributors Corp.. rebottles it from Akorn's NDC 17478-263.
Where the pills inside were 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 |
| Akorn | Location not on file | Makes it, tests it and sterilizes it | Not inspected on record |
| Akorn | Location not on file | Packages it and labels it | Not inspected on record |
Recalls
- Oct 13, 2022 · Class II · Akorn, Inc.
CGMP Deviations:
Lots: Lot: 0L42A, 0L50A, EXP 10/31/2022; 1C64A, 1C76A, EXP 2/28/2023; 1G53A, EXP 6/30/2023; 1J26A, 1J25A, 1J48A, 1J54A, EXP 8/31/2023 - Dec 26, 2019 · Class III · Akorn, Inc.
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Lots: Lot 9E52A, exp 04/2021
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Proparacaine: every company that makes it
- Form
- solution
- Strength
- 5 mg per 1 mL
- Approval
- ANDA ANDA040074
- On the market since
- Sep 29, 1995
- Package NDCs
21695-530-15- Official label
- DailyMed (National Library of Medicine), updated Oct 25, 2011
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?