FDA recall D-0044-2024

Product

Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-737-86

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2023-10-04

Report date

2023-10-25

Termination date

2024-02-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0044-2024