Recall: D-0231-2022

Class II - Potentially Harmful

Class IIClassification

2021-10-25Initiated

TerminatedStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

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

Reason

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

Distribution

Distributed to one distributor who may have further distribute the product nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.