Recall Enforment Report D-0231-2022

Multi event Drug Recall Enforcement Report Class II voluntary initiated by SUN PHARMACEUTICAL INDUSTRIES INC, originally initiated on 10-25-2021 for the 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 The product was recalled due to incorrect product formulation: an incorrect grade of crospovidone was used to manufacture the product.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0231-202210-25-202111-17-2021Class II36,786 30-count bottlesTadalafil 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 # 16714-077-01Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.Ongoing
D-0230-202210-25-202111-17-2021Class II73,957 30-count bottlesTadalafil 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 # 16714-075-01Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
16714-074Tadalafil TadalafilTablet, Film CoatedOralNorthstar RxllcHuman Prescription Drug
16714-075Tadalafil TadalafilTablet, Film CoatedOralNorthstar RxllcHuman Prescription Drug
16714-076Tadalafil TadalafilTablet, Film CoatedOralNorthstar RxllcHuman Prescription Drug
16714-077Tadalafil TadalafilTablet, Film CoatedOralNorthstar RxllcHuman Prescription Drug