Medicines safety alerts, messages and guidance

Drug Safety Update: May 2012 (Volume 5, Issue 10)

Tue, 22 May 2012 10:13:00 UTC

Drug Safety Update is essential reading for all healthcare professionals, bringing you the very latest information and advice to support the safer use of medicines.

Class 3 Drug Alert (Action Within 5 days): Kappin Limited - Fulsovin 125mg/5ml Oral Suspension - EL (12)A/19

Thu, 17 May 2012 10:29:00 UTC

Kappin Limited is recalling all remaining stock of this product because stability testing has indicated that the product will not comply with the required specifications for the duration of the shelf-life.

Class 3 Drug Alert (Action Within 5 days): Kappin Limited - Fulsovin 125mg/5ml Oral Suspension - EL (12)A/19

Thu, 17 May 2012 09:52:00 UTC

Class 3 Drug Alert (Action Within 5 days): Teva UK Limited - Levothyroxine 100mcg Tablets in Teva UK and Numark liveries - EL(12)A/18

Wed, 09 May 2012 10:22:00 UTC

Teva UK Limited is recalling all remaining in-date stock of Levothyroxine 100mcg tablets in Teva UK and Numark liveries.

Class 3 Drug Alert (Action Within 5 days): Teva UK Limited - Levothyroxine 100mcg Tablets in Teva UK and Numark liveries - EL(12)A/18

Wed, 09 May 2012 09:52:00 UTC

Teva UK Limited is recalling all remaining in-date stock of Levothyroxine 100mcg tablets in Teva UK and Numark liveries.

Class 4 Drug Alert: Priadel Liquid (Lithium Citrate 520mg/5ml equivalent to Lithium Carbonate 204mg/5ml) - Sanofi - EL (12)A/17

Thu, 03 May 2012 15:22:00 UTC

Sanofi has informed the MHRA that they have received several reports that Priadel Liquid appears cloudy rather than clear. A detailed investigation has been carried out and this has shown that the cloudiness is not due to microbial contamination. The root cause has been attributed to a change of source for one of the excipients, Xanthan gum.

Class 4 Drug Alert: Priadel Liquid (Lithium Citrate 520mg/5ml equivalent to Lithium Carbonate 204mg/5ml) - Sanofi - EL (12)A/17

Thu, 03 May 2012 14:43:00 UTC

Information sent to healthcare professionals in April about the safety of medicines

Tue, 01 May 2012 14:46:00 UTC

Copies of letters sent to healthcare professionals in April 2012 to inform of new safety information and advice.

Class 4 Drug Alert: Epistatus, Midazolam 10 mg in 1 ml Buccal Liquid x 5 ml (M11) – unlicensed medicine made under Manufacturers Specials licence MS 123 manufactured by Special Products Ltd - EL(12)A/16

Tue, 24 Apr 2012 10:22:00 UTC

Further to our previous alerts EL(12)A/08 and EL(12)A/10 Special Products Ltd have informed us that they plan to distribute five batches of this product with the original 1.0 ml syringe. There will be no further supply of product with the 1.5 ml syringe.

Company-led drug recall: Sodium Bicarbonate 8.4% Intravenous Infusion, 100ml bottle. PL 03551/0069 - BBraun Medical Ltd - CLDA(12)A/08

Fri, 20 Apr 2012 12:40:00 UTC

BBraun have received reports of precipitation whilst in use, remaining stock to be quarantined

Class 4 Drug Alert: Printed box error which potentially affects all plastic boxed Pre Filled Syringes supplied by Aurum (trading as Martindale Pharma) - EL (12)A/15

Thu, 05 Apr 2012 13:36:00 UTC

Further to the Class 4 Drug Alerts EL(11)A/27 and EL(11)A/28 issued in November 2011, Aurum Pharmaceuticals Limited (trading as Martindale Pharma) has informed us of another incident related to incorrect screen printing on a plastic box containing a pre-filled syringe.

Class 4 Drug Alert: Printed box error which potentially affects all plastic boxed Pre Filled Syringes supplied by Aurum (trading as Martindale Pharma) - EL (12)A/15

Thu, 05 Apr 2012 13:20:00 UTC

Information sent to healthcare professionals in March about the safety of medicines

Mon, 02 Apr 2012 09:37:00 UTC

• Copies of letters sent to healthcare professionals in March 2012 to inform of new safety information and advice.

Company-led drug recall: Various Carboplatin products - EBEWE Pharma Ges.m.b.H. Nfg.KG - CLDA(12)A/07

Fri, 30 Mar 2012 15:37:00 UTC

EBEWE Pharma Ges.m.b.H. Nfg.KG is recalling all unexpired batches as a precaution because particles were observed in some batches of the product 15-18 months after the date of manufacture during a stability monitoring programme.

Information sent to healthcare professionals in February about the safety of medicines

Tue, 27 Mar 2012 08:47:00 UTC

Copies of letters sent to healthcare professionals in February 2012 to inform of new safety information and advice.

Company-led drug recall: TechneScan MAG3, packs of five vials, PL 32873/0018 - Covidien UK Ltd - CLDA(12)A/06

Mon, 26 Mar 2012 13:06:00 UTC

Covidien UK Ltd is recalling this device because during routine quality control testing of subsequent batches of Tc99m kits, glass particles were found inside a product vial.

Company-led drug recall: Sodium Bicarbonate 8.4% 100ml bottles - B.Braun Medical Ltd - CLDA(12)A/05

Fri, 23 Mar 2012 16:05:00 UTC

B.Braun have recalled this device as they have received reports of precipitation whilst in use. Remaining stock to be quarantined.

Class 1 Drug Alert: Wockhardt UK Ltd - Co-codamol 8/500 tablets (codeine phosphate 8mg, paracetamol 500mg) containing rogue Co-codamol 30/500 tablets - EL (12)A/14

Fri, 23 Mar 2012 12:47:00 UTC

We have received reports of rogue higher-strength Co-codamol 30/500 tablets found in blisters of one batch of the lower strength 8/500 tablets. The defect has been confirmed by analytical testing and examination carried out by Wockhardt UK Ltd

Class 4 Drug Alert: Novartis Vaccines and Diagnostics GmbH – Rabipur - EL (12)A/13

Wed, 21 Mar 2012 09:41:00 UTC

Novartis Vaccines has informed us that there is a potential problem with the packaging of the syringes supplied with specific batches of Rabipur.

Class 2 Drug Alert (Action Within 48 Hours): Teva UK Ltd - Prednisolone EC 2.5mg and 5mg tablets in pots - EL (12)A/12

Tue, 20 Mar 2012 11:23:00 UTC

Further to Drug Alert EL (11)A/31 of 15 December 2011 concerning the recall of batches Prednisolone EC 2.5 mg and 5 mg tablets in blister packs, Teva UK Ltd has informed us that the recall is being extended to Prednisolone EC products packed in pots.

Company-led drug recall: Bevacizumab Intravitreal Injection 1.25mg/0.05ml - Moorfields Pharmaceuticals - CLDA(12)A/04

Tue, 13 Mar 2012 15:06:00 UTC

Moorfields Pharmaceuticals hasrecalled the above lots of this unlicensed Special following a number of reports of suspected sterile endophthalmitis. This is listed in the SPC for Avastin, when used off-label, but the number of reports is higher than with previous batches and a precautionary recall has been instigated.

Class 3 Drug Alert (Action Within 5 Days): Teva UK Limited - Cisplatin 1mg/ml, concentrate for solution for infusion - EL (12)A/11

Tue, 13 Mar 2012 12:11:00 UTC

Teva UK Limited is recalling Cisplatin 1mg/ml concentrate for solution for infusion because it has been given a three year shelf life whereas the approved shelf life is eighteen months.

Class 4 Drug Alert: Additional information following our alert EL(12)A/08 issued on 28 February 2012 - EL(12)A/10

Tue, 06 Mar 2012 16:05:00 UTC

Further to our previous alert EL(12)A/08 for batches 25658 and 27229, Special Products Ltd have informed us that they need to release a further batch of this product. This will ensure that there is continuity of supply until improved stock is available in mid April 2012.

Class 4 Drug Alert: Aurum Pharmaceuticals Limited (t/a Martindale Pharma) - Adrenaline (Epinephrine) Injection 1:1000 for Anaphylaxis, 1mg in 1ml, 1x1ml Prefilled Syringe and Atropine Sulphate Injection 600mcg in 1ml, 1xml Prefilled Syringe - EL(12)A09

Thu, 01 Mar 2012 16:09:00 UTC

Aurum Pharmaceuticals Limited (trading as Martindale Pharma) has informed us that there is an error on the syringe label of the above batches associated with the scale of gradations which show nominal volume at 0.1ml intervals.

Class 4 Drug Alert: Epistatus, Midazolam 10mg in 1ml Buccal Liquid x 5ml (M11) - EL(12)A/08

Tue, 28 Feb 2012 17:45:00 UTC

Special Products Ltd carried out several modifications to this unlicensed product in December 2011. Information about the changes appears not to have been adequately passed on to users of the product and has the potential to result in product overdose.