Class 4 Medicines Defect Information: Glaxosmithkline Consumer Healthcare (UK) Trading Limited, various products, EL(20)A/22

GSK has informed us that due to a machinery defect with the printing line, a small number of packs may not have the batch number and expiry date printed on the outer cartons. The correct information is printed on the blister pack and there is no concern with the product quality.

MDR Number

MDR 009-04/20

Company name

Glaxosmithkline consumer healthcare (uk) trading limited

Product description

Beechams All In One Tablets (GSL) PL 44673/0007

Active Pharmaceutical Ingredient(s): paracetamol, guaifenesin, phenylephrine hydrochloride

Batch Number Expiry Date Pack Size First Distributed
7H3L 31/10/2022 16 30/01/2020
7H3P 31/10/2022 16 30/01/2020

Piriteze Allergy Tablets (GSL) PL 44673/0097

Active Pharmaceutical Ingredient: cetirizine

Batch Number Expiry Date Pack Size First Distributed
9P9X 31/10/2022 7 11/02/2020
848E 30/09/2022 30 30/01/2020
848F 31/10/2022 30 30/01/2020
C89U 31/12/2022 30 17/02/2020
C92J 31/12/2022 30 21/02/2020
CF8J 30/11/2022 7 18/02/2020
DD6Y 31/12/2022 14 21/02/2020
EM9F 31/12/2022 14 21/02/2020
EM9H 31/12/2022 14 21/02/2020
TT6W 31/07/2022 7 5/12/2019
V39W 30/09/2022 7 4/12/2019
VK4A 30/09/2022 30 5/12/2019

Piriton Allergy Tablets (P) PL 44673/0093

Active Pharmaceutical Ingredient: chlorphenamine

Batch Number Expiry Date Pack Size First Distributed
SC9X 30/09/2022 60 02/01/2020
SD2E 30/09/2022 60 02/01/2020
SD2F 30/09/2022 60 02/01/2020
VK4C 30/09/2022 30 02/01/2020
VK4D 30/09/2022 30 02/01/2020

Day Nurse Capsules (P) PL 44673/0069

Active Pharmaceutical Ingredient(s): paracetamol, pseudoephedrine hydrochloride, pholcodine

Batch Number Expiry Date Pack Size First Distributed
XL3H 31/10/2022 20 5/12/2019
XL3J 31/10/2022 20 5/12/2019
XR2H 31/10/2022 20 5/12/2019

Night Nurse Capsules (P) PL 44673/0071

Active Pharmaceutical Ingredient(s): paracetamol, dextromethorphan hydrobromide, promethazine hydrochloride

Batch Number Expiry Date Pack Size First Distributed
XU2N 30/09/2022 10 6/12/2019
XU2S 30/09/2022 10 6/12/2019
XU2T 31/10/2022 10 9/12/2019
YR2B 30/09/2022 10 6/12/2019

Brief description of the problem

GSK has informed us that due to a machinery defect with the printing line, a small number of packs from the affected batches above may not have the batch number and expiry date printed on the outer cartons. The correct information is printed on the blister pack and there is no concern with the product quality. These packs are not being recalled and this notice is for information.

Advice for healthcare professionals, retailers and wholesalers

If it is noticed that the pack(s) have missing information on the batch number and expiry date on the outer carton, do not supply and return to the company.

If member(s) of the public have queries about pack(s) that have missing information on the batch number and expiry date, please check that the product(s) are from the batch(es) listed above. If the affected pack(s) are from batch(es) listed above, please inform the patient or consumer that this defect has been confirmed by the company, and that the information can still be found on the blisters inside the box (see image above see PDF document). If the affected pack(s) are not from batch(es) listed above, please quarantine the product(s) and contact the company for further information.

As a general reminder, patients who experience side effects from taking any medicines should be encouraged to report a suspected problem or incident via the Yellow Card scheme www.mhra.gov.uk/yellowcard and seek medical advice accordingly.

Further Information

For more information or medical information queries, please contact GSK Customer Relations at 0800 783 8881 or email customer.relations@gsk.com

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Download the attachment

Class 4 Medicines Defect Information: Glaxosmithkline Consumer Healthcare (UK) Trading Limited EL (20)A/22

Updates to this page

Published 20 April 2020