PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: January 17, 2024 Initiated: December 29, 2023 #D-0222-2024

Product Description

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

Details

Units Affected
47,976 bottles
Distribution
Nationwide within the United States
Location
East Brunswick, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Rising Pharma Holding, Inc.. Units affected: 47,976 bottles.
Why was this product recalled?
Presence of Foreign Tablets/Capsules
Which agency issued this recall?
This recall was issued by the FDA Drug on January 17, 2024. Severity: Moderate. Recall number: D-0222-2024.