The MHRA has allowed company-led recalls for many years which do not result in the issue of a full-distribution drug alert. Usually these are cases with a known and limited distribution and it is seen as beneficial not to contact large numbers of unaffected individuals.
We have now decided to publish limited information about these recalls which will allow anyone to seek more information from the company concerned if they wish. Company-led recalls will only be published in this area and there will be no MHRA Drug Alert, MHRA email alert, Drug Safety Update notice or CAS alert to primary care trusts.
If you have any concerns or questions about this scheme, please contact Ian Holloway, DMRC Manager ian.holloway@mhra.gsi.gov.uk or telephone 020 3080 6608.
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20 Apr 2012 | Company-led drug recall: Sodium Bicarbonate 8.4% Intravenous Infusion, 100ml bottle. PL 03551/0069 - BBraun Medical Ltd - CLDA(12)A/08
BBraun have received reports of precipitation whilst in use. Remaining stock to be quarantined.
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30 Mar 2012 | Company-led drug recall: Various Carboplatin products - EBEWE Pharma Ges.m.b.H. Nfg.KG - CLDA(12)A/07
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.
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26 Mar 2012 | Company-led drug recall: TechneScan MAG3, packs of five vials, PL 32873/0018 - Covidien UK Ltd - CLDA(12)A/06
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.
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23 Mar 2012 | Company-led drug recall: Sodium Bicarbonate 8.4% 100ml bottles - B.Braun Medical Ltd - CLDA(12)A/05
B.Braun have recalled this device as they have received reports of precipitation whilst in use. Remaining stock to be quarantined.
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13 Mar 2012 | Company-led drug recall: Bevacizumab Intravitreal Injection 1.25mg/0.05ml - Moorfields Pharmaceuticals - CLDA(12)A/04
Moorfields Pharmaceuticals have recalled 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.
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21 Feb 2012 | Company-led drug recall: Adrenaline (Epinephrine) 1:10,000 1x10ml Ampoule - Aurum Pharmaceuticals Limited - CLDA(12)A/03
Aurum Pharmaceuticals Limited is recalling the this specific batch as there is a labelling error on the carton. The total adrenaline content of each ampoule is expressed in white print in the blue box on each face of the carton as ‘100micrograms in 10ml’, whereas it should be expressed as ‘1mg in 10ml’.
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15 Feb 2012 | Company-led drug recall: Eltroxin (Levothyroxine) 100mcg tablets PL 10972/0032 - Goldshield Ltd - CLDA(12)A/02
Goldshield Ltd are recalling the above batch from wholesalers due to a potential failure in content uniformity. We understand that this product has only been supplied to three wholesalers and none of the batch has been distributed beyond wholesaler level.
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24 Jan 2012 | Company-led drug recall: Gaviscon Advance Aniseed Suspension, 500ml bottles - Reckitt Benckiser (UK) Ltd - CLDA(12)A/01
Reckitt Benckiser (UK) Ltd has recalled this product as a small portion of two batches of this product has been exposed to cold temperatures, which has resulted in non reversible solidification of the contents.
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20 Dec 2011 | Company-led drug recall: Glucose 5% IV Infusion 500 ml Viaflo - Baxter Healthcare Limited - CLDA(11)A/19
Baxter Healthcare Limited has recalled a batch of this product as two bags have been found to contain paper.
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14 Dec 2011 | Company-led drug recall: Vistide 75 mg/ml concentrate for solution for infusion - Gilead Sciences International Limited - CLDA(11)A/18
Gilead Sciences International Limited is recalling listed batches of this product as a precaution due to the possibility of particulate contamination.
