Product Detail

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.

Recall Number D-452-2013

Classification Class III

Code Info Lot No: 3037382, Exp 09/13

Product Distributed Qty 1,621 boxes

Reason For Recall Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.

Event Detail

Event Id 65115

Product Type Drugs

Status Ongoing

Recalling Firm
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
City Rockford

State IL
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-05-15

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide