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
Product summary
- 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
out-of-specification