Class III
Terminated
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 Initiated
- May 15, 2013
- Posted
- May 29, 2013
- Recall Number
- D-452-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,621 boxes
- Firm Location
- Rockford, IL, United States
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
Lot / Code Info
Lot No: 3037382, Exp 09/13
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