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Class II · ModerateRecall completed

Aripiprazole

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberBatches: a)P2006421, P2004882, P2004939, P2004883, P2004940, P2004942, P2004943, P2004944, Exp. Date 8/31/2023; P2107593, P2106907, P2106906, P2106908, P2106909, Exp. Date 10/31/2024; b)P2102144, Exp. Date 3/31/2023; P2106903 Exp. Date 10/31/2023; P2204437, Exp. Date 7/31/2025;
Where it was soldUnited States including Puerto Rico and Canada
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

CGMP Deviations: recalling drug products following an FDA inspection.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India foreign manufacturer
Brand nameARIPIPRAZOLE
Generic nameARIPIPRAZOLE
Active ingredient(s)ARIPIPRAZOLE
Distributed by / forAccord Healthcare, Inc., Durham, NC 27703
NDC16729-280-10
Show the full FDA record
Full product labelAripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5; b) 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-382 213. India
Recalling firmAccord Healthcare, Inc.
DistributionUnited States including Puerto Rico and Canada
Quantity539,004 bottles
Recall initiated2023-02-07
Report date2023-03-08
Recall completed2024-04-22
Recall numberD-0367-2023
ClassificationClass II
FDA statusTerminated
Origin on fileDurham NC United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.