Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count ...
FDA Recall #D-0553-2023 — Class II — March 16, 2023
Product Description
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
Recalling Firm
Northwind Pharmaceuticals LLC — Indianapolis, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
a)164 bottles; b) 198 bottles
Distribution
Nationwide with the United States
Code Information
a) Lot #: F113892002, Exp. Date 08/31/2023; F113892201, Exp. Date 11/30/2023 b) Lot #: F113892001, Exp. Date 08/31/2023; F113892202, Exp. Date 11/30/2023; F113892203, Exp. Date 12/31/2023
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated