Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send Mylan Institutional, Inc. (d.b.a. UDL Laboratories) to request your refund or repair — edit it as you like.
Subject: Recall D-452-2013 — Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Mylan Institutional, Inc. (d.b.a. UDL Laboratori Hello, I own a Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) that is covered by recall D-452-2013 from Mylan Institutional, Inc. (d.b.a. UDL Laboratories). I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
