Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 ...
FDA Recall #D-0368-2023 — Class II — February 7, 2023
Product Description
Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2; b) 100-count bottle NDC 16729-281-01, UPC 3 16729 28101 0; 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
312,864 bottles
Distribution
United States including Puerto Rico and Canada
Code Information
Batches: a) P2004997, P2004998, P2004999, Exp. Date 8/31/2023; P2101206, Exp. Date 1/31/2024 , P2102486, Exp. Date 4/30/2024; P2106247, P2105375, Exp. Date 7/31/2024; P2107239, P2107240, Exp. Date 10/31/2024; b) P2204222 Exp. Date 7/31/2025, P2105374 Exp. 7/31/2024, P2203449 Exp. 5/31/2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated