FDAClass IIOctober 17, 2018

Prevacid 24HR recall: CGMP Deviations

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.

Why was Prevacid 24HR recalled?

CGMP deviations

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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.
Recalling firm
GLAXOSMITHKLINE NEBRASKA
Quantity
5,548,673 bottles
Distribution
Nationwide USA and Puerto Rico
Recall date
October 17, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls