Precautionary recall of Amoxicillin Actavis Powder
Precautionary recall of Amoxicillin Actavis Powder for Oral Suspension (125 mg/5 mL and 250 mg/5 mL)
Auckland, 17 July 2014 - Actavis New Zealand Ltd confirms that as a precautionary measure and in close co-ordination with the New Zealand Medicines and Medical Devices Safety Authority, Medsafe, in New Zealand, the company has issued a consumer level recall of all batches of Amoxicillin Actavis Powder for Oral Suspension 125mg/5mL and 250mg/5mL. This recall is being madeto all pharmacies, pharmaceutical wholesalers and consumers.
The recall of Amoxicillin Actavis Powder for Oral Suspension is being taken as a precaution due to a potential for glass fragments to be present in the bottle. Amoxicillin Actavis Powder for OralSuspension is supplied in a glass bottle and there is a small possibility of glass fragments entering the powder.
The company is advising all healthcare professionals, distributors and consumers to return product to the supplier through the appropriate channels, as part of the recall.
Actavis is working closely with Medsafe to rigorously investigate the matter.
Actavis is committed to being a global leader in improving the health and quality of people’s lives worldwide. The company is committed to adherence to all applicable regulatory requirements andindustry standards, and ensures compliance by continuous assessment and monitoring of the oversight of the existing quality systems, and application of evolving industry guidelines and regulations.
Actavis New Zealand Ltd. is a subsidiary specialty pharmaceutical company Actavis plc (NYSE: ACT). Headquartered in Dublin, Ireland, Actavis plc is focused on developing, manufacturing andcommercializing high quality affordable generic and innovative branded pharmaceutical products for patients around the world.
Actavis markets a broad portfolio of branded and generic pharmaceuticals and develops innovative medicines for patients suffering from diseases principally in the central nervous system,gastroenterology, women's health, urology, cardiovascular, respiratory and anti-infective therapeutic categories. The Company is an industry leader in product research and development, with one ofthe broadest brand development pipelines in the pharmaceutical industry, and a leading position in the submission of generic product applications. Actavis has commercial operations in more than 60countries and operates more than 30 manufacturing and distribution facilities around the world.