Drug product

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.

D-452-2013

May 15, 2013

Class III

Product summary

Firm: Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Event: Event 65115
Status: Terminated
Classification: Class III
Quantity: 1,621 boxes
Official record key: drug-enforcement:D-452-2013

Official wording

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

Code information: Lot No: 3037382, Exp 09/13

Distribution pattern: Nationwide

Derived failure modes

Potency or specification failure
reason.potency_specification_failure · v1.0.0

out-of-specification