Aripiprazole Tablets recalled over manufacturing violations

Recall date

January 10, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Hetero Labs, Ltd. - Unit III recalls Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway,…

Recall number

D-0594-2018

FDA classification

Class II

Brand / firm

Hetero Labs, Ltd. - Unit III

Sold / distributed

NJ Only

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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