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Cummulative Update

mhra
by Kazeem Olalekan

Over the last month, a number of important alerts have been posted on the MHRA website which we, at bookapharmacist.com, will like to draw attention (NOTE: We continue to Tweet MHRA alerts on our Twitter page – @bookapharmacist under the hashtag #mhra – so be sure to follow our tweets):

 

29/10/2013 – Class 2 Alert – Imigran Injection/Subject

GlaxoSmithKline UK are recalling the above batches of Imigran Injection/Subject to pharmacy, clinic and wholesaler level as a small number of syringes may have needles protruding from the needle shield.

Affected batches

Imigran Injection/Subject

Description Batch number Expiry date Pack size
Imigran Inj/Subject Treatment C640404 15 May 2015 2×0.5ml
Imigran Inj/Subject Refill C639899 4 June 2015 2×0.5ml
Imigran Inj/Subject Treatment C638748 4 June 2015 2×0.5ml
Imigran Inj/Subject Refill C638737 4 June 2015 2×0.5ml
Imigran Inj/Subject Treatment C636954 4 June 2015 2×0.5ml
Link

 25/10/2013 – Class 2 Alert –  NovoMix 30 Penfill, 100U/ml, 3ml, Suspension for Injection and NovoMix 30 FlexPen , 100U/ml, 3ml, Suspension for Injection

Novo Nordisk A/S is recalling the batches of above insulins due to the possibility of a very small number of cartridges within each batch containing too much or too little insulin.

Novomix 30 Penfill, Distributed in the UK by Novo Nordisk Ltd

Batch number Expiry date Pack size
CS6D422 Oct 2014 5 x 3ml
CS6C628 Sep 2014 5 x 3ml
CS6C411 Aug 2014 5 x 3ml
Link

Novomix 30 FlexPen, Parallel Distributed in the UK

Batch number Expiry date Pack size
CP50912 Oct 2014 5 x 3ml
CP50750 Jul 2014 5 x 3ml
CP50639 Jul 2014 5 x 3ml
CP51706 Jan 2015 5 x 3ml
CP50940 Oct 2014 5 x 3ml
CP50928 Oct 2014 5 x 3ml
CP50903 Oct 2014 5 x 3ml
CP50914 Oct 2014 5 x 3ml
CP50640 Jul 2014 5 x 3ml
CP51095 Oct 2014 5 x 3ml
CP50904 Oct 2014 5 x 3ml
CP50650 Jul 2014 5 x 3ml
CP51098 Oct 2014 5 x 3ml
CP50915 Oct 2014 5 x 3ml
CP50412 Jul 2014 5 x 3ml
CFG0003 Sept 2014 5 x 3ml
CFG0002 Sept 2014 5 x 3ml
CFG0001 Sept 2014 5 x 3ml
CP50902 Oct 2014 5 x 3ml
CP50749 Jul 2014 5 x 3ml
CP50393 Jul 2014 5 x 3ml
CP50950 Oct 2014 5 x 3ml
CP51025 Oct 2014 5 x 3ml
CP50751 Jul 2014 5 x 3ml
CP50375 Jul 2014 5 x 3ml
CP50420 Jul 2014 5 x 3ml
CP51097 Oct 2014 5 x 3ml
CP50641 Jul 2014 5 x 3ml
CP51096 Oct 2014 5 x 3ml
CP50392 Jul 2014 5 x 3ml
Link

17/10/2013 – Class 2 Alert: Wockhardt UK Limited – Deficiencies in good manufacturing practice (GMP) in the India Manufacturing site

Following Drug Alert EL(13)A/19 a second Wockhardt manufacturing site in India has been inspected.  The inspection identified deficiencies in good manufacturing practice (GMP) and the GMP certificate for this site has also been withdrawn.

These products have been tested on importation and Qualified Person (QP) released. There is no evidence of a risk to patient safety from products currently in the UK market; however it is considered that the products have not been manufactured in line with GMP requirements.

Wockhardt UK Limited

Description Product License
Amiloride HCl 5mg Tablets PL 29831/0006
Clarithromycin 250mg Tablets PL 29831/0476
Clarithromycin 500mg Tablets PL 29831/0477
Gliclazide 80mg Tablets PL 29831/0103
Quinine Sulphate 300mg Tablets PL 29831/0182
Tamsulosin Pinexel 400mcg Capsules PL 29831/0366
Aspirin 300mg Tablets, Wockhardt & Co-op livery PL 29831/0015
Extra Pain Control Caplets, Co-op livery PL 29831/0164
Ibuprofen 200mg Caplets, Superdrug livery PL 29831/0289
Max Strength Cold & Flu Relief, Superdrug livery PL 29831/0169
Paracetamol Extra Strength Tablets, Best In, Galpharm, Happy Shopper & Spar livery PL 29831/0166
Link1 Link2

The key question we ask at bookapharmacist.com is this: Are the recent alerts a result of increasing manufacturing lapses or a result of better regulatory regime with more inspections? The former will fill us with dread and the later with hope. We hope the wave of defects in the manufacturing processes in October is just a blip.

 

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