Exact FDA event identifier

Event 77936

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

Event summary

Timeline bucket: August 03, 2017
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: MEDLINE INDUSTRIES 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

Vitamin A&D Ointment (petroleum 93.5%), Skin Protectant, NET Wt. 0.18 OZ (5g), Manufactured for Medline Industries, Inc., Northfield, IL 60093 USA. NDC: 53329-090-16

D-1138-2017

Recall number: D-1138-2017
Initiated: August 03, 2017
Classification: Class II
Status: Terminated
Recalling firm: MEDLINE INDUSTRIES INC
Quantity: 462 cases, 144 packets per case

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling Mixup

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jelly. The boxes and outer case are correctly labeled as A&D ointment.

Code information

Lot Number: A-K-8383

Distribution pattern

Nationwide