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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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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