SUN PHARMACEUTICAL INDUSTRIES INC recalls Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactur
Recalled November 17, 2021 · FDA recall D-0231-2022 · SUN PHARMACEUTICAL INDUSTRIES
Hazard
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product. · FDA Class II
Units
36,786 30-count bottles
Sold at
Distributed to one distributor who may have further distribute the product nationwide.
Description
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
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
Manufacturer(s)
SUN PHARMACEUTICAL INDUSTRIES INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →