Reported Mar 8, 2023 · Terminated
Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as
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 15 mg Rx Only, Packaged as
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2 |
| 2 | 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 |
| 3 | India |
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 P2004997, P2004998, P2004999, Exp. Date 8/31/2023 2 P2101206, Exp. Date 1/31/2024 , P2102486, Exp. Date 4/30/2024 3 P2106247, P2105375, Exp. Date 7/31/2024 4 P2107239, P2107240, Exp. Date 10/31/2024 5 P2204222 Exp. Date 7/31/2025, P2105374 Exp. 7/31/2024, P2203449 Exp. 5/31/2025 - Amount recalled
- 312,864 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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