Recall: D-0594-2018

Class II - Potentially Harmful

Class IIClassification

2018-01-10Initiated

TerminatedStatus

Hetero Labs, Ltd. - Unit IIIFirm

Product

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

Reason

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

Distribution

NJ Only

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.