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.
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