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

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.

From:
Medicines and Healthcare products Regulatory Agency
Published
2 March 2020
Message type:
Medicines recall/notification
Medical specialty:
Pharmacy
Issued:
2 March 2020

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)

Updates to this page

Published 2 March 2020
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