FDA recall D-0275-2024

Teva Pharmaceuticals USA, Inc · Class II · drug

Product

Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-2510-30

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide

Key facts

Status: Ongoing
Initiation date: 2024-01-08
Report date: 2024-02-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0275-2024