FDA-Drug2021-11-17Class II
Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-075-01
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
73,957 30-count bottles
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-075-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0230-2022More SUN PHARMACEUTICAL INDUSTRIES INC recalls
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