Class 2 Medicines Recall: Molipaxin 100 mg capsules (one batch)

Winthrop Pharmaceuticals UK Limited (trading as Zentiva) is conducting a precautionary recall of a single batch of Molipaxin 100 mg capsules due to a potential issue with the metal detector during manufacture of the batch (EL(18) A/01).

Product information

MDR number

MDR 061-12/17

Company name

Winthrop Pharmaceuticals UK Limited Trading as Zentiva

Product description

Molipaxin 100 mg capsules (PL 17780/0618)

(Trazodone hydrochloride)

Batch number/expiry

Batch Number Expiry Date Pack Size First Distributed
3650817 July 2020 56 capsules 16 October 2017

Brief description of the problem

A precautionary recall is being carried out due to the potential that during manufacture of the batch, the metal detector may not have functioned and therefore that the presence of metal particles would not have been detected, if they were present. Although there is no evidence of metal particles within units from the batch, the batch is being recalled as a precautionary measure.

Advice for healthcare professionals & wholesalers

Please return affected stock from this batch to your supplier.

Medical information enquiries

For Medical information enquiries, please contact uk-medicalinformation@sanofi.com.

Stock enquiries

For stock enquiries, please contact GB-CustomerServices@sanofi.com.

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Class 2 Medicines Recall - Molipaxin 100 mg capsules (MDR 061-12/17)

Recipients of this Drug Alert 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, hospitals, mental health trusts, general practitioners and community pharmacists for information.

Published 3 January 2018