Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC | Grand Island, NY, United States | Makes it and tests it | Problems found, fixed voluntarilyOct 13, 2023 · 14 inspections, 2 with FDA action |
Recalls
- Aug 13, 2014 · Class II · Fresenius Kabi USA, LLC
CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.
Lots: Lot 6007698, Exp. 03/16
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Propranolol: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 1 mg per 1 mL
- Approval
- ANDA ANDA075826
- On the market since
- Sep 7, 2001
- Package NDCs
63323-604-01- Official label
- DailyMed (National Library of Medicine), updated Jan 12, 2023
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