Enforcement Report - Week of March 20, 2013
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Product Detail
| Product Description | PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04 |
|---|---|
| Recall Number | D-199-2013 |
| Classification | Class III |
| Code Info | Lot/Exp Date: YP0035 11/13; YP0140 12/13; YP0136 12/13; AB0077 2/14; AH0133 5/14 |
| Product Distributed Qty | 64675 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 |
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