NAFDAC Declares Infusion, Intravenous Fluids Contaminated
By Ben Nwabuwe
National Agency for Food, Drug Administration and Control (NAFDAC), has ordered the immediate withdrawal of some Infusions/-Intravenous Fluids, which it declared contaminated, stating that the products failed the pyrogen and micro biological tests.
In a statement signed by NAFDAC Public Relation Officer, Mrs. Christiana Obiazikwor, the survey is a follow up of the agency recent nation-wide survey on water for injection, stating that a total of 566 samples were tested, comprising of 42 products from 8 manufacturers.
"Nine out of the 42 failed pyrogen and micro biological tests, which are critical parameters for the safety of such products. NAFDAC is requesting that all institutions in possession of the contaminated infusion return them immediately to the nearest NAFDAC office".
She further explained that the affected companies has been instructed to recall all the affected batches from their distributors, adding that NAFDAC officers all over the country has also been instructed to mop up all such products in circulation in their states.
The contaminated brands are as follows: Dana Dextrose 5% W/V infusion, with batch number 01692, 15179. Manufactured on 12/03, Expiring date 11/05 and 05/03 exp. Date 04/06 respectively.
Dana Dextrose 4.3% W/V and saline 0.18% W/V infusion. Batch number 41NU618, 41N0597, 4N06630, manufactured on 02/04, 12/03, 03/04, with expiring date, 01/07, 11/06, 02/07.
Dana Darrows Half strength infusion with batch number D51/200446, manufactured on 05/02, expiring date, 04/05, all from Dana Pharmaceutical Ltd, Minna, Niger State.
Dextrose 5% W/V infusion, batch number GZ/1903, manufactured on 07/03, with expiring date, 07/05, a product of Afric Pharmaceutical PLC, Imo State.
Others includes: Dextrose 5% W/V infusion with batch number 091194, manufactured on 09/01, expiring date 09/04 and sodiu Chloride 0.9% W/V infusion, batch number 024042, 1010332, manufactured on 03/04, 08/03, expiring date 02/07, 07/06.
Sodium Chloride 0.9% W/V infusion, batch number 014028, manufactured on 01/04 expiring date 01/07, products of Biomedical Services Co. Ltd, Ilorin.
Unidex 55% W/V Glucose IV infusion, batch number, 4040, manufactured on 01/04, expiring date, 12/06 and Unideex 50-50% W/V Glucose IV infusion, batch number 1005, manufacturing date, 08/01, expiring date, 07/04, all from Unique Pharmaceutical Lit, Sango-Otta.
Also, GMP reassessment of all infusion producing plants have been conducted by NAFDAC and reports showed some major lapses in three out of four plants currently in production.
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