FDA recall D-0222-2024

Product

buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, INDIA, NDC 16571-862-03

Reason for recall

Presence of Foreign Tablets/Capsules

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2023-12-29

Report date

2024-01-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0222-2024