FDA recall D-1341-2020

Product

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.

Reason for recall

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

Distribution

Nationwide in the U.S.

Key facts

Status

Terminated

Initiation date

2020-06-10

Report date

2020-07-01

Termination date

2022-01-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tajpura, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1341-2020