RB Recalls Liquid Mucinex Products Over Labeling Issues
Reckitt Benckiser is voluntarily recalling 1.5 million units of four varieties of its Mucinex liquid cold medicines nationwide because the back labels may not show they contain acetaminophen and other active ingredients.
The 135 affected lots — involving Mucinex Fast-Max Night Time Cold & Flu, Mucinex Fast-Max Cold & Sinus, Mucinex Fast-Max Severe Congestion & Cough and Mucinex Fast-Max Cold, Flu & Sore Throat — correctly label the product on the front of the bottle and list all active ingredients, but may not have the correct drug facts on the back label, the April 21 recall notice says.
RB has a number of affected units still within its control and, after inspection, the number of affected units appears to be small, with the ratio of incorrect to correct labels less than 1 percent, spokeswoman Lynn Kenney said.
In addition to acetaminophen, the products contain dextromethorphan, guaifenesin, phenylephrine and/or diphenhydramine. Acetaminophen is of particular concern because of the risks to people with liver problems, the company says.
The recall, which has not yet been assigned an FDA classification, was prompted by a confirmed report from a retailer, RB says. The recall — the firm’s first for an OTC product in the U.S. — has triggered an internal investigation of the firm’s quality control system, Kenney says.
Stay up to date on GMP stories like this one by subscribing to Drug GMP Report. For over 20 years, drug manufacturers have relied on DGR for the latest on FDA’s interpretation and enforcement of cGMPs and the Quality Systems Regulation — information you need to stay in compliance.