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.
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.
Lot numbers, UPCs & expiration codes
Lot No: 3037382, Exp 09/13
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-452-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 15, 2013
- FDA report date
- May 29, 2013
- Quantity
- 1,621 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Original FDA data
Every field from FDA enforcement report D-452-2013, exactly as published.
Show all FDA fields
- City
- Rockford
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 65115
- Address
- 1718 Northrock Ct
- Code information
- Lot No: 3037382, Exp 09/13
- Postal code
- 61103-1201
- Report date
- May 29, 2013
- Product type
- Drugs
- Recall number
- D-452-2013
- Classification
- Class III
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Product quantity
- 1,621 boxes
- Termination date
- May 7, 2015
- Reason for recall
- Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- May 15, 2013
- Initial firm notification
- Letter
- Center classification date
- May 22, 2013