Ghana Food and Drugs Board orders Pfizer to recall substandard drug Camoquin Plus
The Food and Drugs Board on Thursday ordered the recall of substandard Camoquin-Plus suspension manufactured by Pfizer on the Ghanaian market.
A statement issued by the Board in Accra on Thursday, has therefore advised the public not to patronise the anti- malarial drug which have been found to be substandard and should also report anyone found offering them for sale to the nearest FDB office.
The substandard Camoquin-Plus suspension, which is an antimalarial medicine for children with Batch numbers 985 and 986, was manufactured by Pfizer at their pharmaceutical manufacturing plant in Senegal (having the manufacturer’s address as Pfizer Afrique de l’Quest, BP 3857 – Dakar R. P. – Senegal).
It said the laboratory analysis of the product had revealed that it did not meet the quality specification therefore the products would ultimately be destroyed.
The FDB had therefore directed wholesalers, pharmacy, licensed chemical shops, hospitals or clinics that had in stock these medicines (with the specified batch numbers) to immediately return them to the importer, distributor, manufacturer or to the FDB.
Health-care providers, as well as hospital and clinics were advised not to prescribe Camoquin-Plus from Pfizer with the above mentioned Batch numbers to patients since that would lead to therapeutic failure in the treatment of malaria.
Furthermore, parents were advised not to administer this substandard Camoquin-Plus from Pfizer (with the stated batch numbers) to their children suffering from malaria, since administration of this substandard Camoquin-Plus might lead to severe life threatening complications or death.
The statement said further investigations were on-going and regulatory sanctions should be applied to the Pfizer Pharmaceutical Company for flouting Section 14 of the Food and Drugs Law.
It states that ‘Any person who labels, packages, sells or advertises any drug, cosmetic, medical device or chemical substance in contravention of any regulation made under this Law or in a manner that is false, misleading or deceptive as regards its character, constitution, value, potency, quality, composition, merits or safety, commits an offence.’
The FDB assured the general public of its readiness to enforce its mandate of ensuring public health and safety at all times.
Source: GNA