In yet another recall of acetaminophen, Midway Importing is recalling nearly 165,000 boxes of Sedalmex. But Midway is not the producer. That is Merck KGaA, which manufactured the pain reliever at a plant in Mexico.
According to the most recent FDA Enforcement Report, Midway is recalling 164,332 boxes of Sedalmex, a combo of acetaminophen and caffeine. The notice said that the recall occurred because of potential cross-contamination with the antibiotic cephalosporin.
A notice from the California Board of Pharmacy said that the voluntary recall was based on evaluation of data that showed some "points out of limits of cephalosporin traces in surrounding areas to manufacturing" of the product but that no actual cross contamination has been confirmed. There have not been any adverse reactions reported.
The Illinois-based Medline this month began voluntarily recalling one lot of its 500-mg, uncoated, compressed 100-tablet bottles, which it said were mislabeled as "Acetaminophen 325mg" instead of "Acetaminophen 500mg." The company said the error is not easily identifiable by a consumer--or even a prescriber. And that recall came after Reckitt Benckiser had to recall 1.5 million bottles of cold meds with acetaminophen in them, also because of a labeling issue.
Acetaminophen, a nonaspirin pain reliever, is found in more than 600 over-the-counter products. Because of the potential toxicity, the FDA and other regulators are very careful when there is a potential for consumers to get wrong dose.