D-0275-2024 Class II Ongoing
FDA drug recall D-0275-2024 was initiated by Teva Pharmaceuticals USA, Inc on Jan 8, 2024 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is ongoing. Affected quantity: 10,672 30-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 7, 2024
- Initiation Date
- Jan 8, 2024
- 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0275-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026