Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals,...

FDA Recall #D-0554-2023 — Class II — March 16, 2023

Recall #D-0554-2023 Date: March 16, 2023 Classification: Class II Status: Ongoing

Product Description

Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-487-52

Reason for Recall

CGMP Deviations

Recalling Firm

Northwind Pharmaceuticals LLC — Indianapolis, IN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

23 bottles

Distribution

Nationwide with the United States

Code Information

Lot #: F114302001, Exp. Date 05/31/2023

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated