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Public Alert No: 026/2020-Alert on Petazone (Dexamethasone Injection) Batch Number 190314 Due to Unsatisfactory Report of Laboratory Analysis

November 10, 2020,

The National Agency for Food and Drug Administration and Control (NAFDAC) following an investigation on Petazone (Dexamethasone Injection) batch number 190314 sampled and analyzed the product.

The result of laboratory analysis was observed to be unsatisfactory. The report of the analysis on the product established that the affected batch of the product failed sterility test and assay having just 0.2% content of dexamethasone (active ingredient) as against 90-110% expected.

The details of the affected batch of the product are:

Product Name Petazone (Dexamethasone Injection IM/IV) 1ml

Dexamethasone Sodium Phosphate USP equivalent to Dexamethasone Phosphate 4mg

Product Manufacturer HUBEI TIANYO Pharmaceutical Co.Ltd, No.7 Dufu Block, Jianshe Road, Xiangyang,Hubei, China.
Batch Number 190314
Manufacturing Date 03/2019
Expiry Date 03/2022
NRN 04-9115

NAFDAC has heightened surveillance in the States and the Federal Capital Territory, Abuja to prevent or stop the distribution and sale of Petazone (Dexamethasone Injection IM/IV) 1ml Batch Number 190314.

All distributors, wholesalers and retailers are implored to submit Petazone (Dexamethasone Injection IM/IV) 1ml Batch Number 190314 in their possession to the nearest NAFDAC office.

Healthcare providers and other members of the public are to contact the nearest NAFDAC office with any information on distribution and sale of Petazone (Dexamethasone Injection IM/IV) 1ml Batch number 190314

Consumers are advised to report adverse events related to use of medicines to the nearest NAFDAC office, NAFDAC PRASCOR [20543 or 0800-1-NAFDAC (0800-1-623322) TOLL FREE from all networks] or via pharmacovigilance@nafdac.gov.ng or via eReporting platform available on the NAFDAC website www.nafdac.gov.ng

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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