FDA recall D-0553-2023

Product

Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.

Reason for recall

CGMP Deviations

Distribution

Nationwide with the United States

Key facts

Status

Ongoing

Initiation date

2023-03-16

Report date

2023-05-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0553-2023