FDA recall D-0541-2024

Rising Pharma Holding, Inc. · Class III · drug

Product

Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-531011, India, NDC 64980-411-10

Reason for recall

Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2024-05-16
Report date
2024-06-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
East Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0541-2024