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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80041

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

Open FDA event record

Event summary

Timeline bucket
May 11, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
L. Perrigo Company

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

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

Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84); b) 10-count (NDC 45802-580-46); c) 24-count (NDC 45802-580-62), Rx only, Mfd. by: Aveva Drug Delivery Systems, A Nitto Denko Company, Miramar, FL 33025 Distributed by Perrigo, Allegan, MI 49010

D-0816-2018
Recall number
D-0816-2018
Initiated
May 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
L. Perrigo Company
Quantity
569,520 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective delivery system

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective delivery system

Code information

Lot #: a) 46397, 46457 Exp 03/19; 46621, Exp 04/19; 46894, 46904, 46905, Exp 06/19; 47133, Exp 07/19; 47153, Exp 08/19; 47154, 47213, 47214, Exp 09/19; b) 46695, Exp 04/19; 46994, 47012, Exp 07/19; 47322 10/19; c) 46822, Exp 05/19 ; 47155, 47212, Exp 09/19

Distribution pattern

Nationwide in the U.S.A.