FDA recall D-0231-2022

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 for recall

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.

Key facts

Status

Terminated

Initiation date

2021-10-25

Report date

2021-11-17

Termination date

2022-09-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0231-2022