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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 numberLot #: ARI17089, ARI17090, Exp. 5/2019
Where it was soldNJ Only
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: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.

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 byCamber Pharmaceuticals, Inc.
Brand nameARIPIPRAZOLE
Generic nameARIPIPRAZOLE
Active ingredient(s)ARIPIPRAZOLE
Distributed by / forCamber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India
NDC31722-827-30
Show the full FDA record
Full product labelAripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India, NDC 31722-827-30
Recalling firmHetero Labs, Ltd. - Unit III
DistributionNJ Only
Quantity3000 bottles
Recall initiated2018-01-10
Report date2018-02-14
Recall completed2020-09-21
Recall numberD-0594-2018
ClassificationClass II
FDA statusTerminated
Origin on fileHyderabad N/A India

Related

Recent drug recallsCheck another medication

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.