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

Alka-Seltzer Original Alka-Seltzer XS (EL (17)A/03)

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.

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