Class 2 medicine recall High risk 2 March 2020

AOP Orphan Pharmaceuticals AG, Tetrabenazine 25 mg tablets, PL 21344/0015

Yes – this has been recalled
The problem
AOP Orphan Pharmaceuticals AG is recalling all unexpired stock of a batch of Tetrabenazine 25 mg tablets (from pharmacies and wholesalers) as a precautionary measure due to out of specification results for the assay, obtained during routine stability testing.
What to do
Check the batch number on your pack against the list below. Do not stop taking a prescribed medicine without talking to your pharmacist, GP or prescriber first – they can check your supply and swap it if needed.
Source: Medicines and Healthcare products Regulatory Agency (MHRA) Official notice ↗

MDR Number

MDR 194-02/20

Company name

AOP Orphan Pharmaceuticals AG

Product description

Tetrabenazine 25 mg tablets PL 21344/0015

  • Batch Number: T1704UK
  • Expiry Date: 09/2020
  • Pack Size: 112
  • First Distributed: 31/12/2017

Advice for healthcare professionals

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Company contacts for further information

For more information or medical information queries, please contact medinfo@aoporphan.com.

For stock control queries, please contact orderservice@aoporphan.com.

Recipients should bring it to the attention of relevant contacts by copy of this letter.

NHS Regional teams are asked to forward this to relevant clinics, general practitioners and community pharmacists.

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Class 2 Medicines recall: AOP Orphan Pharmaceuticals AG, Tetrabenazine 25 mg tablets, PL 21344/0015, (EL (20)A/13)

Updated 2 March 2020. This page summarises an official notice. Details can change – always follow the official notice.

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