Exact FDA event identifier

Event 74502

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

Event summary

Timeline bucket: June 22, 2016
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Teva North America

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

Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract Pharmaceuticals Limited, Canada, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0093-0661-16

D-1455-2016

Recall number: D-1455-2016
Initiated: June 22, 2016
Classification: Class II
Status: Terminated
Recalling firm: Teva North America
Quantity: 8,052 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

Foreign Substance

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.

Code information

Lot # 95113, exp 01/2017

Distribution pattern

Nationwide