FDA recall D-452-2013

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) · Class III · 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.

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

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-05-15
Report date: 2013-05-29
Termination date: 2015-05-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Rockford, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-452-2013