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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04 Lot/Exp Date: YP0035 11/13; YP0140 12/13; YP0136 12/13; AB0077 2/14; AH0133 5/14 Class III Does Not Meet Monograph: Budesonide may be slightly above or below the specification range. 64675 cartons D-199-2013
PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04 Lot/Exp date: AH0054 Exp 5/14; AK0125 Exp 7/14 Class III Does Not Meet Monograph: Budesonide may be slightly above or below the specification range. 28,476 cartons D-198-2013
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