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
Reported: February 7, 2024 Initiated: January 8, 2024 #D-0275-2024
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
Details
- Recalling Firm
- Teva Pharmaceuticals USA, Inc
- Units Affected
- 10,672 30-count bottles
- Distribution
- Nationwide
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Teva Pharmaceuticals USA, Inc. Units affected: 10,672 30-count bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 7, 2024. Severity: Moderate. Recall number: D-0275-2024.
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