Reported Mar 8, 2023 · Terminated

Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-10, UPC 3 16729 28310 6; b) 100-count…

Accord Healthcare, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Accord Healthcare, Inc. · 1009 Slater Rd Ste 210B · Durham, NC · 27703-8446

Is this the product you have?

    • Aripiprazole Tablets
    • USP 30 mg Rx Only
    • a) 30-count bottle
    • NDC 16729-283-10
    • UPC 3 16729 28310 6
    • b) 100-count bottle
    • NDC 16729-283-01
    • UPC 3 16729 28301 4
  • Manufactured forAccord Healthcare, Inc., Durham, NC 27703
  • Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India
Lot codes and dates

10 of 10 products

Products covered by this recall
#Product as published
1P2005477, Exp. Date 9/30/2023
2P2100002, Exp. Date 12/31/2023
3P2101359 Exp. Date 2/28/2024
4P2105409, Exp. Date 7/31/2024
5P2107447, Exp. Date 10/31/2024
6P2203388 Exp. Date 5/31/2025
7P2101859 Exp. Date 2/28/2023
8P2107056, Exp. Date 10/31/2023
9P2203066, Exp. Date 5/31/2024
10P2206130, Exp. Date 8/31/2024
Amount recalled
88,728 bottles

This recall covers 67 products

The agency filed one notice per product. You are reading one of them; the other 66 are below.

54 more are in the archive.

Where it was sold

Why it was recalled

CGMP Deviations: recalling drug products following an FDA inspection.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 22, 2024 · Data as of Sep 19, 5:06 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.