Recalls / Class III
Class IIID-452-2013
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.
- Affected lot / code info
- Lot No: 3037382, Exp 09/13
Why it was recalled
Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
Recalling firm
- Firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1718 Northrock Ct, N/A, Rockford, Illinois 61103-1201
Distribution
- Quantity
- 1,621 boxes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-05-15
- FDA classified
- 2013-05-22
- Posted by FDA
- 2013-05-29
- Terminated
- 2015-05-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-452-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.