FDA recall D-0088-2019

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 for recall

CGMP deviations

Distribution

Nationwide USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2018-09-26

Report date

2018-10-17

Termination date

2020-11-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lincoln, NE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0088-2019