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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64041

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 11, 2013
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
AstraZeneca LP

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04

D-198-2013
Recall number
D-198-2013
Initiated
January 11, 2013
Classification
Class III
Status
Terminated
Recalling firm
AstraZeneca LP
Quantity
28,476 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot/Exp date: AH0054 Exp 5/14; AK0125 Exp 7/14

Distribution pattern

Nationwide

drug · product 2 of 2

PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04

D-199-2013
Recall number
D-199-2013
Initiated
January 11, 2013
Classification
Class III
Status
Terminated
Recalling firm
AstraZeneca LP
Quantity
64675 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot/Exp Date: YP0035 11/13; YP0140 12/13; YP0136 12/13; AB0077 2/14; AH0133 5/14

Distribution pattern

Nationwide