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: 1A08A, EXP 12/31/2022 - Oct 4, 2021 · Class II · Akorn, Inc.
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Lots: Lot 0B61A, Exp 01/31/2022
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Betaxolol: every company that makes it
- Form
- solution/ drops
- Strength
- 5 mg per 1 mL
- Approval
- ANDA ANDA075386
- On the market since
- Apr 1, 2003
- Package NDCs
17478-705-1017478-705-1117478-705-1217478-705-25- Official label
- DailyMed (National Library of Medicine), updated May 23, 2022
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?