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: 3650817
- Expiry Date: July 2020
- Pack Size: 56 capsules
- First Distributed: 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.
Download document
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.