A-S Medication Solutions, LLM has voluntarily recalled nearly 200,000 bottles of extra-strength acetaminophen 500mg tablets due to a mislabeling issue. According to the Food and Drug Administration (FDA), the bottles have “an incomplete prescription drug label rather than the required OTC Drug Facts label.”
If the safety warnings on the OTC label are not considered, acetaminophen could be potentially harmful. The correct label includes warnings about liver damage if the recommended dose is exceeded; if users combine with excessive consumption of alcohol; or if consumers are allergic to the active ingredient.
Humana included the 100-count bottles as part of Health Essentials Kits for its members. The impacted bottles were likely distributed nationwide between January 14, 2021, and March 15, 2021, with expiration dates of either July 31, 2022, or August 31, 2022.
So far, there have been no reports of adverse events concerning the recalled product. However, the FDA is requesting that all affected bottles be returned.
Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.