FDA recall D-0533-2018

Product

Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8575-2); b) 100g (NDC 58597-8575-6);c) 500g (NDC 58597-8575-7); d) 1000g (NDC 58597-8575-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Reason for recall

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Distribution

Nationwide within USA.

Key facts

Status

Terminated

Initiation date

2018-02-09

Report date

2018-02-28

Termination date

2019-12-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waterford, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0533-2018