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Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 ...

FDA Recall #D-0414-2023 — Class II — February 7, 2023

Recall #D-0414-2023 Date: February 7, 2023 Classification: Class II Status: Terminated

Product Description

Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7; b) 500-count bottle NDC 16729-369-16, UPC 3 16729 36916 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

Reason for Recall

CGMP Deviations: recalling drug products following an FDA inspection.

Recalling Firm

Accord Healthcare, Inc. — Durham, NC

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

36,773 bottles

Distribution

United States including Puerto Rico and Canada

Code Information

Batches: a) P2002522, Exp. Date 4/30/2023; P2005817, P2005816, Exp. Date 10/31/2023; P2203687, Exp. Date 6/30/2025; b) P2002521, Exp. Date 4/30/2023; P2005818, Exp. Date 10/31/2023; P2100075, Exp. Date 12/31/2023; P2100996, P2100997, P2100998, P2100999, Exp. Date 1/31/2024;

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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