Exact FDA event identifier

Event 78505

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

Event summary

Timeline bucket: November 10, 2017
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Bayer HealthCare Pharmaceuticals, Inc.

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

Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Morristown, NJ 07962 NDC 0280-2160-36 UPC 3128431310577

D-0135-2018

Recall number: D-0135-2018
Initiated: November 10, 2017
Classification: Class III
Status: Terminated
Recalling firm: Bayer HealthCare Pharmaceuticals, Inc.
Quantity: 104,128 HDPE bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed Stability Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications

Code information

Lot # NAA3T0X; Exp. 07/18

Distribution pattern

Natonwide