GlaxoSmithKline ($GSK) is having to recall an asthma drug after a contract manufacturer determined that batches distributed to a host of countries around the world could have glass particles in them.
The U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) said the drugmaker had recalled two batches of Ventolin syrup in its home country, but a GSK spokeswoman said in an email that the company was recalling 15 batches shipped to Belgium, Cyprus, Estonia, Holland, Lithuania, Malta and to French speaking countries in Africa.
Eleanor Bunch said, "The reason for the recall is an isolated manufacturing issue at a glass bottle supplier site which has resulted in a very small number of Ventolin Syrup bottles with a defect which could potentially result in a risk of glass fragments in the bottle." Bunch said the incidence of affected bottles was believed to be fewer than one in 1,000 bottles; however, in the interest of patient safety, GSK recalled the affected batches in agreement with local regulatory authorities. There have been no adverse reactions reported or complaints about the products.
"We've carried out a thorough investigation with them, to identify the source of the defect, and the likely percentage of defects in the manufactured batches--and we've now put in place actions with the manufacturer and their supplier to prevent this from happening again," Bunch said.
In November, GSK had to recall 7 batches of one of its children's vaccines from Canada and Australia after finding bacteria in the plant in Belgium where they were manufactured. The company said then that the vaccines had all passed testing, leaving little chance the product was tainted, but recalled the product as a precaution.
The FDA in the U.S. has been urging drugmakers to work up quality agreements with their contract manufacturers as a way of clearly spelling out responsibilities and hopefully avoiding some manufacturing problems.
- here's the MHRA notice
- read the in-Pharmatechnologist.com story