Product Safety Recalls

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ARIPIPRAZOLE Recall D-0367-2023

Description: Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5; b) 100-count bottle, NDC 16729-280-01, UPC 3 16729 28001 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India

ARIPIPRAZOLE Recall D-0367-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0367-2023
Event ID91657
Original Package?1
Active SubstanceARIPIPRAZOLE
Drug RouteORAL
DistributionUnited States including Puerto Rico and Canada
Quantity539,004 bottles
Recall ReasonCGMP Deviations: recalling drug products following an FDA inspection.
Drug ClassificationClass II
Drug Code Info20230308
Product NDC16729-278 16729-279 16729-280
Product NUIN0000175430
Drug UPC316729280105 316729280013
Pharma Class (EPC)Atypical Antipsychotic [EPC]
Recall Initiation Date20230207
Report Date20230308
Classification Date20230302
Address1009 Slater Rd Ste 210B
Durham, NC 27703-8446
United States
Recalling FirmAccord Healthcare, Inc.
Initial Notification Letter
Unique Ingredient Identifier82VFR53I78
Drug Application NumberANDA206251
Structured Product Labeling (SPL ID)ed7d1a33-7a1d-8ab1-e053-2a95a90a6813
Structured Product Labeling (SPL Set ID)85cc7d25-414b-4b6f-a03a-48af908a16a1
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