Reported Mar 8, 2023 · Terminated

Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210 9; b)…

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?

3 of 3 products

Products covered by this recall
#Product as published
130-count bottle, NDC 16729-282-10, UPC 3 16729 28210 9
2100-count bottle, NDC 16729-282-01, UPC 3 16729 28201 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382
3India
Lot codes and dates

6 of 6 products

Products covered by this recall
#Product as published
1P2100787, P2100788, Exp. Date 1/31/2024
2P2104736, Exp. Date 6/30/2024
3P2105492, Exp. Date 8/31/2024
4P2107172, P2107175, Exp. Date 10/31/2024
5P2203043, Exp. Date 5/31/2025
6P2104086 Exp. Date 6/30/2024, P2205370 Exp. 8/31/2025
Amount recalled
170,448 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, 5:07 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.