FDA recall D-0539-2023

Product

Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05

Reason for recall

Out of specification (OOS) for Spectroscopic Identification test by IR.

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2023-03-17

Report date

2023-04-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0539-2023