Idarubicin 1mg/ml injection 5 & 10 ml - recall

(Teva UK Limited) red precipitate found during stability testing under cold storage conditions - class 2 action within 48 hours. (EL (14)A/13)

13 August 2014

Class 2 medicines recall

Action within 48 hours

Hospital ward, hospital pharmacy, clinic and wholesale-level recall

MDR 09-08/14

Product details

Teva UK Limited

Idarubicin 1mg/ml injection 5 & 10 ml

(Idarubicin)

PL 00289/1080

Alert details

Batch number   Expiry date   Pack size   First distributed
3320413   Apr-16   5 ml   12-Jul-2013
3330413   Apr-16   10 ml   12-Jul-2013

Teva UK Limited is recalling, as a precautionary measure, 2 batches of Idarubicin 1mg/ml injection following discovery of a red precipitate during stability testing under cold storage conditions. Adverse effects in patients are not expected due to this issue, but cannot be excluded. No complaints or adverse reaction reports on the batches mentioned above which may be related to this issue have been received by the company to date.

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

Recipients of this drug alert should bring it to the attention of relevant contacts by copy of this letter.

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