Alka-Seltzer Original & Alka-Seltzer XS - recall of some batches due to an issue with the blister foil
(Bayer plc) Remaining stock of affected batches should be quarantined for uplift by Bayer - class 3 action within 5 days (EL (17)A/03)
Product information
EL number
EL (17)A/03
MDR number
MDR 96-01/17
Company name
Bayer plc
Product description
Alka-Seltzer Original: PL 00010/0511
Alka-Seltzer XS: PL 00010/0510
Batch number/expiry
| Product | Batch no | Expiry date | Pack size | First distributed |
|---|---|---|---|---|
| Alka-Seltzer Original | BTAH310 | 31 Mar 2019 | 1 x 10 | 20 Jul 2016 |
| Alka-Seltzer Original | BTAH311 | 31 Mar 2019 | 1 x 10 | 12 Aug 2016 |
| Alka-Seltzer Original | BTAH320 | 28 Feb 2019 | 1 x 20 | 22 Jun 2016 |
| Alka-Seltzer Original | BTAHBE0 | 31 May 2019 | 1 x 20 | 09 Jun 2016 |
| Alka-Seltzer Original | BTAHLE0 | 30 Apr 2019 | 1 x 10 | 14 Jun 2016 |
| Alka-Seltzer XS | BTAHE33 | 30 Nov 2018 | 1 x 20 | 27 Jul 2016 |
| Alka-Seltzer XS | BTAHE35 | 30 Nov 2018 | 1 x 20 | 27 Jul 2016 |
| Alka-Seltzer XS | BTAHNX2 | 28 Feb 2019 | 1 x 20 | 02 Sep 2016 |
| Alka-Seltzer XS | BTAHW52 | 31 Mar 2019 | 1 x 20 | 07 Nov 2016 |
| Alka-Seltzer XS | BTAHE32 | 30 Nov 2018 | 1 x 20 | 16 Jun 2016 |
| Alka-Seltzer XS | BTAHE34 | 30 Nov 2018 | 1 x 20 | 19 Jun 2016 |
| Alka-Seltzer XS | BTAHNX1 | 28 Feb 2019 | 1 x 20 | 10 Aug 2016 |
| Alka-Seltzer XS | BTAHNX3 | 28 Feb 2019 | 1 x 20 | 28 Sep 2016 |
Brief description of the problem
Bayer plc is voluntarily recalling the above batches due to an issue with the blister foil. A problem with the blistering process has resulted in the potential for small holes or cracks being present in the aluminium layer of the tablet blister material, which are not visible to the consumer. This could result in compromise of the moisture barrier provided by the aluminium layer. Bayer has assessed this defect as unlikely to pose a safety risk for consumers, therefore affected batches are not being recalled to patient level.
All remaining units of the affected batches should immediately be quarantined. Bayer is contacting potentially affected customers by letter and will arrange uplift of affected stock following receipt of a form listing affected stock in hand. A copy of the form is attached for any customers who may not receive a letter from Bayer.
Company details
For stock enquiries, please contact Bayer plc by telephone on 01635 563920 or by email to orders-uk@bayer.com
For medical enquiries please contact Bayer plc by telephone on 01635 563232 or by email to consumerhealthuk@bayer.com
Download document
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 for action. NB It is not necessary to forward this notice to GPs.