Manufacturers and importers are obliged to report to the MHRA any quality defect in a medicinal product which could result in a recall or restriction on supply. Other users and distributors of medicinal products are encouraged to do this.
Where a defect is considered to be a risk to public health, the marketing authorisation holder withdraws the affected product from use and the MHRA issues a 'Drug Alert' letter. This alert is classified from 1 to 4 depending upon the risk presented to the public health by the defective product. Class 1 is the most critical, for example serious mislabelling, microbial contamination or incorrect ingredients, and requires immediate recall; Class 4 is the least critical and advises 'caution in use'.
Recent Drug Alerts relevant to pharmacists
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09 May 2012 | Class 3 Drug Alert (Action Within 5 days): Teva UK Limited - Levothyroxine 100mcg Tablets in Teva UK and Numark liveries - EL(12)A/18
Teva UK Limited is recalling all remaining in-date stock of Levothyroxine 100mcg tablets in Teva UK and Numark liveries.
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03 May 2012 | Class 4 Drug Alert: Priadel Liquid (Lithium Citrate 520mg/5ml equivalent to Lithium Carbonate 204mg/5ml) - Sanofi - EL (12)A/17
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.
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24 Apr 2012 | 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
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.
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05 Apr 2012 | 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
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.
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23 Mar 2012 | 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
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.
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21 Mar 2012 | Class 4 Drug Alert: Novartis Vaccines and Diagnostics GmbH – Rabipur - EL (12)A/13
Novartis Vaccines has informed us that there is a potential problem with the packaging of the syringes supplied with specific batches of Rabipur.
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20 Mar 2012 | Class 2 Drug Alert (Action Within 48 Hours): Teva UK Ltd - Prednisolone EC 2.5mg and 5mg tablets in pots - EL (12)A/12
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.
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13 Mar 2012 | Class 3 Drug Alert (Action Within 5 Days): Teva UK Limited - Cisplatin 1mg/ml, concentrate for solution for infusion - EL (12)A/11
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.
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06 Mar 2012 | Class 4 Drug Alert: Additional information following our alert EL(12)A/08 issued on 28 February 2012 - EL(12)A/10
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.
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28 Feb 2012 | Class 4 Drug Alert: Epistatus, Midazolam 10mg in 1ml Buccal Liquid x 5ml (M11) - EL(12)A/08
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.
