Mylan Recalls Budesonide Capsules Due to Dissolution Testing Failures
Mylan Institutional, Inc. is recalling 1,621 boxes of Budesonide Capsules, 3 mg, because routine stability testing showed out-of-specification dissolution results.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The issue is a quality control failure (dissolution) rather than a direct safety hazard like contamination or mislabeling.
Plain-English summary
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling 1,621 boxes of Budesonide Capsules, 3 mg, Enteric Coated. The product is packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box and is available by prescription only. The specific lot number is 3037382 with an expiration date of 09/13.
The recall was initiated because routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing. This indicates that the capsules may not release the medication as intended.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or distributor for disposal or replacement.
The recalled product
- 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, ND
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,621
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot No: 3037382
- Exp 09/13
Distribution
Distributed nationwide across the United States.
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