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Safety Alert On Molipaxin 100 Mg Capsules

The National Agency for Food and Drug Administration and Control has been informed that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA), on 5th January, 2018, issued a safety alert on Molipaxin (Trazodone Hydrochloride) 100mg capsule manufactured by Winthrop Pharmaceuticals United Kingdom (UK) under the trademark, Zentiva.

The safety alert was as a result of the precautionary recall of the product by Winthrop Pharmaceuticals Company, due to the discovery that it may contain metal particles during the production process.

Molipaxin Capsules containtrazodone hydrochloride. This belongs to a group of medicines called antidepressants. It can be used to treat anxiety and depression.

Possible Associated Risk

The use of the affected product could result in serious health hazard aside from other side effects which includes dizziness, headache, confusion, weakness and body tremor.

Affected product

The detail of the affected product is as follows:

Product description Manufacturer/ Supplier Batch number Pack size Expiry date First distributed
Molipaxin 100mg Capsule Zentiva 3650817 56 capsules July, 2020 16 October, 2017

Healthcare Provider / Consumer Action

Report adverse events related to the use of the affected products to NAFDAC PRASCOR (20543 Toll free from all networks) or via pharmacovigilance@nafdac.gov.ng.

NAFDAC…… Safeguarding the health of the Nation

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