FDA-Drug2021-11-17Class II
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
SUN PHARMACEUTICAL INDUSTRIES INC
Hazard
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Sold states
Distributed to one distributor who may have further distribute the product nationwide.
Affected count
36,786 30-count bottles
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0231-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief