The Food and Drug Administration (FDA) has released a scathing report slamming the conditions at the factory linked to producing the recalled children’s Tylenol, Motrin, Benadryl, and other over-the-counter drugs that were recalled last weekend. The seventeen page FDA inspection report conducted last month detailed lapses at the facility. The FDA is considering many actions, including potential criminal penalties against the company. In the mean time, Johnson & Johnson is temporarily suspending production at the plant – the company’s only plant that manufactures its liquid pediatric drugs. The company has expressed its concern for the potential to injure children. According to a recent CNN.com article, the federal agency cited the facility for not following quality controls and for not maintaining adequate lab facilities for testing and approval of components and drug products. The FDA’s findings also show that the company bought contaminated raw material from its vendors that tested positive for a type of bacteria that is yet to be identified by the FDA. However, the agency said that the company’s testing showed that the contamination did not reach its finished products.
The company recalled about fifty children’s versions of non-prescription drugs over the weekend for quality concerns. The injury attorneys at Levin & Perconti strongly encourage our readers to follow the FDA’s instructions to immediately discontinue the use of any recalled products. Disposing of the recalled products became a little less confusing in Chicago, with the City of Chicago and Chicago Police teaming to create multiple locations where residents can dispose of expired and/or recalled pharmaceuticals and over-the-counter products.
Read more about the FDA’s scathing report about the Tylenol product recall.