FDA recall D-0761-2023

Product

buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86

Reason for recall

Failed Dissolution Specifications; during stability testing

Distribution

Nationwide in the U.S.A

Key facts

Status

Terminated

Initiation date

2023-05-09

Report date

2023-05-31

Termination date

2024-02-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0761-2023