Exact FDA event identifier

Event 73538

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: February 05, 2016
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: AstraZeneca Pharmaceuticals 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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 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 1

Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler, Rx Only. Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. Manufactured by: Forest Laboratories, Ireland Limited, Dublin 17 Ireland. Product of Spain. NDC: 0310-0800-60.

D-0781-2016

Recall number: D-0781-2016
Initiated: February 05, 2016
Classification: Class II
Status: Terminated
Recalling firm: AstraZeneca Pharmaceuticals LP
Quantity: 148,331 Inhalers

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Defective Delivery System: Some units have actuation counters set to a number other than 60.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System: Some units have actuation counters set to a number other than 60.

Code information

Lot # 1144394, Expiry: 04/2018; Lot # 1145539, Expiry: 04/2018; Lot # 1145868, Expiry: 05/2018.

Distribution pattern

US: Nationwide Including Puerto Rico