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.
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