Prevacid 24HR Capsules
Prevacid 24HR Capsules
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC Voluntary Recal Prevacid 24HR Capsules
For Immediate Release
Items affected at Stater Bros Markets are:
PREVACID 24HR CAPSULES 14 CT 3-00676-28614-3 *SP ITEM
PREVACID 24HR CAPSULES 42 CT 3-00676-28642-6 *SP ITEM
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC Date: September 26, 2018
184 Liberty Corner Drive
Warren, NJ 07059
GSK Customer Service team at 1-800-743-4014, Option “5”, for PREVACID® 24HR 15 mg Lansoprazole Capsules, Recall Event Number 134PREV18.
Dear GSK Customer:
This letter is to inform you that GSK Consumer Healthcare is conducting a voluntary retail level recall of:
Prevacid® 24HR Capsules, 15 mg lansoprazole (14, 28, and 42 counts)
UCC: Please refer to Attachment 1 for full list of impacted UCC codes
UPC: Please refer to Attachment 1 for full list of impacted UPC codes
This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).
In keeping with our commitment to quality, GSK Consumer Healthcare has made the precautionary decision to voluntarily recall all Prevacid® 24HR Capsules lots within expiry at the retail distribution level. This decision is based on microbiological out of specification results obtained for one lot of Prevacid® 24HR Capsules that remains within GSK control and has not been distributed. Although all lots on the market and within expiry have met all release test specifications, current available data cannot exclude potential impact to released product. There is no evidence of a consumer safety concern based on a completed medical assessment that concludes the use of, or exposure to, the affected product is not likely to cause adverse health consequence.
Please note that product is being recalled at the retail level. This is not a consumer level recall.
Affected lots (within expiry) were manufactured between October 8th, 2015, and March 26, 2018, and distributed in the timeframe between January 7th, 2016 and September 2nd, 2018.
GSK Consumer Healthcare is committed to providing the highest quality products to our customers. We regret any inconvenience this recall may cause and appreciate your cooperation.
If you have any questions, please contact our GSK Customer Service team at 1-800-743-4014, Option “5”, for PREVACID® 24HR 15 mg Lansoprazole Capsules, Recall Event Number 134PREV18.