Alembic Pharmaceuticals Limited recalls Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Form…

Recall date

June 10, 2020

Source

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

Recall number

D-1341-2020

FDA classification

Class II

Brand / firm

Alembic Pharmaceuticals Limited

Sold / distributed

Nationwide in the U.S.

Why it was recalled

Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.

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, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA, NDC 62332-097-30.