Status
Terminated
Drug Enforcement D-452-2013
Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
Classification
Class III
Report Date
May 29, 2013
Termination Date
May 7, 2015
Product Information
- Product description
- 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.
- Product quantity
- 1,621 boxes
- Reason for recall
- Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Address
-
1718 Northrock Ct, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-452-2013
- Event ID
- 65115
- Recall initiation date
- May 15, 2013
- Center classification date
- May 22, 2013
- Code info
- Lot No: 3037382, Exp 09/13
- More code info
- —