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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