The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted Nigerians of Petazone (Dexamethasone Injection) batch number 190314 following an investigation on Petazone sample.
According to the report, 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.|
NAFDAC reportedly said that the agency 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.
NAFDAC implored 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.
NAFDAC reportedly admonished 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.