September 2018 FDA Recall Drug by Glaxosmithkline Nebraska
D-0088-2019 - CGMP deviations

This Class II drug recall was voluntarily initiated by Glaxosmithkline Nebraska on September 26, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0088-2019

Reason for Recall
CGMP deviations
Initiated
09-26-2018
Reported
10-17-2018
Quantity
5,548,673 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81041
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
GLAXOSMITHKLINE NEBRASKA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-06-2020
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 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