D-452-2013 Class III Terminated
FDA drug recall D-452-2013 was initiated by Mylan Institutional, Inc. (D.B.A. UDL Laboratories) on May 15, 2013 and is designated Class III. Reason for recall: Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing. The recall status is terminated (terminated May 7, 2015). Affected quantity: 1,621 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- May 29, 2013
- Initiation Date
- May 15, 2013
- Termination Date
- May 7, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,621 boxes
Product Description
Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed by: UDL Laboratories, Inc., Rockford, IL 61103, NDC 51079-020-03.
Reason for Recall
Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
Distribution Pattern
Nationwide
Code Information
Lot No: 3037382, Exp 09/13
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-452-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026