Reported Mar 8, 2023 · Terminated
Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5; 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
| # | Product as published |
|---|---|
| 1 | 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5 |
| 2 | 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 |
| 3 | India |
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 P2006421, P2004882, P2004939, P2004883, P2004940, P2004942, P2004943, P2004944, Exp. Date 8/31/2023 2 P2107593, P2106907, P2106906, P2106908, P2106909, Exp. Date 10/31/2024 3 P2102144, Exp. Date 3/31/2023 4 P2106903 Exp. Date 10/31/2023 5 P2204437, Exp. Date 7/31/2025 - Amount recalled
- 539,004 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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