Reported Feb 14, 2018 · Terminated

Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway,…

Hetero Labs, Ltd. - Unit III

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: Hetero Labs, Ltd. - Unit III · Plot 22-110, Part Ii, Ida · Hyderabad, N/A · N/A

Is this the product you have?

  • Aripiprazole 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
Lot codes and dates
    • Lot #: ARI17089
    • ARI17090
    • Exp. 5/2019
Amount recalled
3000 bottles

Where it was sold

Why it was recalled

CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 21, 2020 · Data as of Sep 19, 5:04 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.