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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 0.5 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