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Three recalls

Abstral 200 microgram sublingual tablets; betahistine dihydrochloride 8mg/16mg tablets

November 26th 2020

Tagged: MHRA alert

By MHRA

Aventis Pharma Limited (t/a Sanofi) is recalling two batches of largactil 50mg/2ml Solution for Injection (chlorpromazine hydrochloride) as a precautionary measure. The affected batches are

Batch Number: A90142Pack Size: 10x2ml ampoulesExpiry Date: 05/2022First Distributed: 08 April 2020
    
Batch Number: A90143Pack Size: 10x2ml ampoulesExpiry Date: 05/2022First Distributed: 10 June 2020

The recall is due to out of specification results obtained for the impurity chlorpromazine sulphoxide, which was suspected to be caused by increased oxidation as a result of higher oxygen content in the headspace of the ampoules.

Healthcare professionals are advised to stop supplying the above batches immediately. Quarantine all stock and return to the supplier.

For stock control enquiries please contact GB-CustomerServices@sanofi.com. Tel: 0800 854 430

For more information or medical information at uk-medicalinformation@sanofi.com. Tel: 0800 035 25 25

Kyowa Kirin Limited is recalling two batches of Abstral 200 microgram sublingual tablets (fentanyl citrate)  as a precautionary measure, due to the reports of double tablets in a single blister pocket.

The affected batches are:

Batch NumberExpiry DatePack SizeFirst Distributed
60897360130 September 2021109 February 2020
60897360230 September 20213028 June 2020

Healthcare professionals are asked to quarantine all remaining stock and return it to their supplier.

For Stock control enquiries please contact: Karen Murray, commercial manager, telephone: +44 (0) 7712 001288; e-mail: karen.murray@kyowakirin.com

For medical information enquiries please  telephone: + 44 (0)1896 664 000 or e-mail: medinfo@kyowakirin.com

For quality information please contact: Martin Smith (Responsible Person), telephone: +44 7904671807 or

e-mail: Martin.Smith@kyowakirin.com

Kent Pharmaceuticals Ltd is recalling three batches each of  Betahistine dihydrochloride 8mg and 16mg tablets due to potential contaminateionwith theophylline. The affected batches are as follows:

Betahistine dihydrochloride 8mg tablets:

Batch NumberExpiry DatePack SizeFirst Distributed
EC106191 October 20228421 October 2020
EC107191 October 2022849 September 2020
EC108191 October 2022844 May 2020

Betahistine dihydrochloride 16mg tablets:

Batch NumberExpiry DatePack SizeFirst Distributed
GY1111901 October 20228421 April 2020
GY1121901 October 20228405 May 2020
GY1131901 October 20228423 September 2020

Healthcare professionals should quarantine all stock and return it to their suppliers.

If patients experience any side effects related to hypersensitivity or those not normally experienced with betahistine, please refer to a member of the healthcare team and report any suspected side effects via the Yellow Card scheme.

For stock control enquiries please contact customer.service@kent-athlone.com

For more information or medical information medical@kent-athlone.com