Reported Mar 8, 2023 · Terminated
Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-279-10, UPC 3 16729 27910 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
| # | Product as published |
|---|---|
| 1 | 30-count bottle, NDC 16729-279-10, UPC 3 16729 27910 9 |
| 2 | 100-count bottle, NDC 16729-279-01, UPC 3 16729 27901 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 |
| 3 | India |
- Lot codes and dates
15 of 15 products
Products covered by this recall # Product as published 1 P2004259, P2004260, P2004261, Exp. Date 7/31/2023 2 P2006799, P2101391, Exp. Date 11/30/2023 3 P2100826, Exp. Date 1/31/2024 4 P2101320, Exp. Date 2/28/2024 5 P2102510, P2102409, P2102407, Exp. Date 3/31/2024 6 P2102410, Exp. Date 3/31/2024 7 P2105251, P2105252, P2105253, Exp. Date 7/31/2024 8 P2107404, P2107029, Exp. Date 10/31/2024 9 P2200260, P2200265, Exp. Date 12/31/2024 10 P2202067, P2202068, Exp. Date 3/31/2025 11 P2204239, Exp. Date 7/31/2025 12 P2006800 Exp. Date 11/30/2023 13 P2102141, Exp. Date 3/31/2024 14 P2104085, Exp. Date 6/30/2024 15 P2107031, P2107466, Exp. Date 10/31/2024 - Amount recalled
- 1,109,904 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Accord Healthcare, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.