Drug Enforcement D-198-2013

Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.

Status

Terminated

Classification

Class III

Report Date

March 20, 2013

Termination Date

July 26, 2013

Product Information

Product description
PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04
Product quantity
28,476 cartons
Reason for recall
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
AstraZeneca LP
Address
50 Otis Street, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-198-2013
Event ID
64041
Recall initiation date
January 11, 2013
Center classification date
March 12, 2013
Code info
Lot/Exp date: AH0054 Exp 5/14; AK0125 Exp 7/14
More code info
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