FDA recall D-0137-2024

Product

buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-738-86

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2023-11-22

Report date

2023-12-13

Termination date

2024-06-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0137-2024