Novartis has had problems with its own consumer health manufacturing because of quality lapses at its plant in Lincoln, NE. Now it is recalling 42 batches of children's liquid cough and cold products in the U.K. because of a manufacturing issue reported by a contractor.
The Swiss drugmaker said in a statement emailed to FiercePharmaManufacturing that there is a "potential manufacturing defect with the tamper seal … which might result in small pieces of plastic being found in the medicine," affecting a range of Tixylix products. The drugmaker said that the recall is entirely precautionary, that there have been no confirmed reports of plastic in bottles and that the potential for it happening is very low.
Novartis ($NVS) has asked that consumers, retail customers and wholesalers in the U.K. send back bottles of 5 different Tixylix cough syrups. It did say that its Tixylix Honey & Lemon product is unaffected by the recall and will continue to be sold. The drugmaker has notified the Medicines and Healthcare Products Regulatory Agency about the potential problem, and on Friday the MHRA announced the recall. The Novartis recall follows one by the Boots pharmacy chain in the U.K., for the same reason. That recall started in November and was expanded last week.
Novartis struggled for several years with manufacturing problems at its OTC plant in Lincoln, which produced its entire Excedrin line, as well as NoDoz, Bufferin and Gas-X Prevention products. The plant closed in 2011 after the FDA found huge problems there, but after spending millions on remediation, the drugmaker has started shipping products from there again. It has, however, narrowed the focus of the facility, limiting it to just two product forms: solid and powder. The move meant laying off 300 workers and taking a $100 million hit for the restructuring. The company decided, instead, it would ramp up OTC manufacturing at a plant in Prangins, Switzerland, where it will invest €150 million ($196.6 million) by 2020 to modernize the plant and expand production.
- here's the MHRA Novartis announcement
- here is the MHRA Boots announcement