Reported May 29, 2013 · Terminated
Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged)…
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mylan Institutional, Inc. (d.b.a. UDL Laboratories) · 1718 Northrock Ct · Rockford, IL · 61103-1201
Is this the product you have?
- Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only
- Manufactured byMylan Pharmaceuticals Inc., Morgantown, WV 26505
- Packaged and Distributed byUDL Laboratories, Inc., Rockford, IL 61103, NDC 51079-020-03
- Lot codes and dates
- Lot No
3037382Exp 09/13
- Lot No
- Amount recalled
- 1,621 boxes
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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