Evacal D3 1500mg/400iu Chewable Tablets - metal contamination in a very small number of tablets

(Teva UK Limited) Precautionary batch recall of Evacal D3 1500mg/400iu Chewable Tablets after metal contamination was identified in a very small number of tablets

Product information

EL number

EL (16)A/16

MDR number

MDR 100-11/16

Company name

TEVA UK Limited

Product description

Evacal D3 1500mg/400iu Chewable Tablets (calcium carbonate / colecalciferol)

PL 0289/1742

Batch number/expiry

Pack size 1 x 56

Batch no Expiry date First distributed
6010615 Dec 2017 15 Jul 2016
6010616 Dec 2017 13 Jul 2016
6010617 Dec 2017 12 Jul 2016
6010618 Dec 2017 19 Jul 2016
6010619 Dec 2017 07 Jul 2016
6010620 Dec 2017 11 Aug 2016
6010621 Dec 2017 29 Jul 2016
6010622 Dec 2017 10 Aug 2016

Pack size 1 x 112

Batch no Expiry date First distributed
6011671 Dec 2017 02 Mar 2016
6011673 Dec 2017 14 Mar 2016
6011674 Dec 2017 04 Mar 2016
6011675 Dec 2017 16 Jun 2016
6011676 Dec 2017 08 Jun 2016

Brief description of the problem

Teva UK Limited is recalling the above batches as a precaution because metal contamination has been identified in a very small number of tablets. All the listed batches were manufactured using the same batch of active pharmaceutical ingredient, which is believed to be the source of the contamination.

Remaining stock of these batches should be quarantined and returned to the original supplier for credit.

Company details

For stock enquiries, please contact Teva UK Limited Customer Service on 0800 590 502

For medical information enquiries please contact Teva UK Limited by phone on 0207 5407117 or by email to medinfo@teva.com.

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Evacal D3 1500mg/400iu Chewable Tablets

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS Regional teams: please cascade to relevant clinics, general practitioners and community pharmacists.

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