Drug Enforcement D-0275-2024

Failed Dissolution Specifications

Status

Ongoing

Classification

Class II

Report Date

February 7, 2024

Termination Date

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Product Information

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
Product quantity
10,672 30-count bottles
Reason for recall
Failed Dissolution Specifications
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Teva Pharmaceuticals USA, Inc
Address
400 Interpace Pkwy Bldg A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0275-2024
Event ID
93740
Recall initiation date
January 8, 2024
Center classification date
January 26, 2024
Code info
Lot # 100047273; Exp. 07/2025
More code info
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