Class II ยท Moderate risk
Vardenafil HCl USP
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
National Drug Code
Is NDC 58597-8575-08 recalled?
Vardenafil HCl USP
Yes — this exact package was recalled
1 FDA recall names the code 58597-8575-08 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
This code is not in the current FDA NDC directory — usual for a product that has since been discontinued or repackaged. The details below come from the recall notices themselves.
Recalls naming this package
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 58597-8049 See recall 2
- 58597-8082 See recall 2
- 58597-8142 See recall 2
- 58597-0077 See recall 1
- 58597-0078 See recall 1
- 58597-0079 See recall 1
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.