Enforcement Report - Week of March 20, 2013
-
Back to Previous Page
Product Detail
| Product Description | PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04 |
|---|---|
| Recall Number | D-198-2013 |
| Classification | Class III |
| Code Info | Lot/Exp date: AH0054 Exp 5/14; AK0125 Exp 7/14 |
| Product Distributed Qty | 28,476 cartons |
| Reason For Recall | Does Not Meet Monograph: Budesonide may be slightly above or below the specification range. |
Event Detail
| Event Id | 64041 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | AstraZeneca LP |
| City | Westborough |
| State | MA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2013-01-11 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
-
