RecallRadar

FDA Drug recall D-0088-2019

Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per bottle in a carton containing 1 bottle (NDC: 0067-6286-14), 2…

On 2018-10-17 the FDA classified a Class II recall of Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per bottle in a carton containing 1 bottle (NDC: 0067-6286-14), 2… by Glaxosmithkline Nebraska, citing CGMP deviations.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0088-2019
ClassificationClass II
Statusterminated
Initiated2018-09-26
Published2018-10-17
Last updated2026-09-13 11:52 UTC
CompanyGlaxosmithkline Nebraska
DistributionUS

Product

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.

Reason

CGMP deviations

Identifiers

code_info
1-bottle cartons lot #: GE2743, GE4570, GG0536, Exp 9/30/2018; GE3445, GG4810, Exp 11/30/2018; A38M, Exp 12/31/2018; K…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, M720

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0088-2019%22

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