Aripiprazole Tablet
FDA Recall NDC 65162-899
Latest: Class II · Status: Terminated · Initiated Jan 26, 2022 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Aripiprazole (NDC 65162-899). A significant event, classified as Class II, was initiated on Jan 26, 2022 by Amneal Pharmaceuticals Llc. The reported reason for this action was: "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Jan 26, 2022
Jan 03, 2024
2 units
Recall Profile & Regulatory Data
Event ID
89450
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
CARDINAL HEALTHCARE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Sep 29, 2024
Product Description
Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 65162-897-03
Batch or Lot Expiration Information
Batch# Batch AR202318
Affected Packages Involved in this Recall
65162-896-03Aripiprazole
65162-896-09Aripiprazole
65162-896-50Aripiprazole
65162-896-11Aripiprazole
65162-897-03Aripiprazole
65162-897-09Aripiprazole
65162-897-50Aripiprazole
65162-897-11Aripiprazole
65162-898-03Aripiprazole
65162-898-09Aripiprazole
65162-898-50Aripiprazole
65162-898-11Aripiprazole
65162-899-03Aripiprazole
65162-899-09Aripiprazole
65162-899-50Aripiprazole
65162-899-11Aripiprazole
65162-901-03Aripiprazole
65162-901-09Aripiprazole
65162-901-50Aripiprazole
65162-901-11Aripiprazole
65162-902-03Aripiprazole
65162-902-09Aripiprazole
65162-902-50Aripiprazole
65162-902-11Aripiprazole
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
