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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81041

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

Open FDA event record

Event summary

Timeline bucket
September 26, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GLAXOSMITHKLINE NEBRASKA

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

Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per bottle in a carton containing 1 bottle (NDC: 0067-6286-14), 2 bottles (NDC: 0067-6286-28) or 3 bottles (NDC: 0067-6286-42), Over-the-counter, Distributed By: GSK Consumer Healthcare, Warren, NJ 07059.

D-0088-2019
Recall number
D-0088-2019
Initiated
September 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
GLAXOSMITHKLINE NEBRASKA
Quantity
5,548,673 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP deviations

Code information

1-bottle cartons lot #: GE2743, GE4570, GG0536, Exp 9/30/2018; GE3445, GG4810, Exp 11/30/2018; A38M, Exp 12/31/2018; K63J, Exp 4/30/2018; H24T, Exp 5/31/2018; RS4U, M721601MA, Exp 7/31/2018; 379H, Exp 8/31/2018; A93E, AE2S, Exp 10/31/2018; GB7D, GS5B, M801001MA, M807901MA, M807902MA, exp 11/30/2019; D88E, Exp 11/30/2020 2-bottle cartons lot#: GJ0440, Exp 1/31/2019; LE6J, Exp 7/31/2018; A93E, Exp 10/31/2018 3-bottle cartons lot#: 17D19N, Exp 8/31/2018; 1GE2743, GE4570, GG0536, Exp 9/30/2018; GA8391, Exp 10/31/2018; GE3445, GA6310, Exp 11/30/2018; GG1094, GH1913, GH8818, M703002EH, M703003EH, M703004EH, M703006EH, M703007EH, M703008EH, M713101EH, M707401MB, M707402MB, M707403MB, M707404MB, M707405MB, M707406MB, M721201MB, M717001MA, M717002MA, Exp 1/31/2018; AF5C, AK2T, AV5T, M713102EH, M713104EH, M716001EH, M716002EH, M716003EH, M716004EH, M716005EH, M721202MB, M721203MB, M721204MB, M717003MA, M717004MA, M717005MA, M717006MA, Exp 4/30/2019; FL8P, FM4K, M720505EH, M720507EH, M720508EH, M720509EH, M721205MB, M721206MB, M721207MB, Exp 5/31/2019; P77N, P77P, PN3Y, R72E, Exp 8/31/2019; 728J, 728K, 728L, 8E6T, A93E, Exp 10/31/2019; H43X, HT4P, M85L, Exp 11/30/2019; T73J, UT9X, UV7Y, Exp 2/29/2019; BR4Y, FN2N, Exp 11/30/2020; MC2P, MJ9F, RC2T, Exp 1/31/2021

Distribution pattern

Nationwide USA and Puerto Rico