D-0275-2024 Class II Ongoing

Recalled by Teva Pharmaceuticals USA, Inc — Parsippany, NJ

Recall Details

Product Type
Drugs
Report Date
February 7, 2024
Initiation Date
January 8, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,672 30-count bottles

Product Description

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 Pattern

Nationwide

Code Information

Lot # 100047273; Exp. 07/2025