FDA-Drug2013-05-29Class III
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.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Hazard
Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
Sold states
Nationwide
Affected count
1,621 boxes
Manufactured in
1718 Northrock Ct, N/A, Rockford, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-452-2013Don't want to check this manually?
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