Medical safety alert

Desloratadine ratiopharm 5mg film-coated tablets - higher than expected levels of impurities detected

(ratiopharm GmbH) Corrected batch numbers from EL (13)A/04 –class 3 action within 5 days. (EL (13)A/04 Rev 1)

26 February 2013

Class 3 medicines recall Action within 5 days

Pharmacy-level recall

MDR 46-12/12

Product details

ratiopharm GmbH

Desloratadine ratiopharm 5mg film-coated tablets (Teva livery)

EU/1/11/746/006

Alert details

Batch number   Expiry date   Pack size   First distributed
009263   30 September 2014   1 x 30   15 February 2012
009264   30 September 2014   1 x 30   15 February 2012
010168   31 March 2015   1 x 30   14 June 2012
010321   31 March 2015   1 x 30   12 June 2012

Please replace the drug alert issued on 13 February 2013 with this revised document. Teva UK Limited has informed us that the batch numbers were expressed incorrectly on the original Alert. The table, above, has now been corrected. The company apologises for any additional inconvenience this may cause.

Teva UK Limited is recalling all remaining stock of the above batches because higher than expected levels of impurities were detected during routine stability testing. Although there are currently no concerns relating to patient safety, it is possible that impurities may exceed specification towards the end of the shelf-life.

Remaining stocks of these batches should be quarantined and returned to the original supplier for credit. For further stock enquiries please contact Teva UK Customer Liaison Team on 0800 590502.

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

Recipients of this drug alert should bring it to the attention of relevant contacts by copy of this letter. Primary care trusts are asked to forward this to relevant clinics and to general practitioners and community pharmacists for information.

MHRA distribution

Further recipients by cascade):

Regional contacts for NHS Trusts and provider units
Chief pharmacists: England, Scotland, Wales, Northern Ireland
Prison health policy unit (DH)
Chief pharmacists:  Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special hospitals
Healthcare Commission for distribution to independent health care establishments
Primary care trusts (England)

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