Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-077-01

Recall Number: D-0231-2022

Firm: SUN PHARMACEUTICAL INDUSTRIES INC

Classification: Class II

Status: Terminated

Report Date: 20211117

Initiation Date: 20211025

Termination Date: 20220901

Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.

Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-077-01