Nearly 200,000 bottles of extra-strength acetaminophen, used to relieve pain and fevers and sold under multiple brand names, are being recalled nationwide due to a mislabeling issue.
A-S Medication Solutions, LLM voluntarily recalled bottles of its Acetaminophen Extra Strength 500 mg tablets because they have "an incomplete prescription drug label rather than the required OTC Drug Facts label," the Food and Drug Administration (FDA) said in a notice.
Representatives for A-S Medication Solutions did not return FOX Business' request for comment.
Acetaminophen "could be potentially harmful if safety warnings contained on the OTC label are not observed," the FDA said.
The proper label is supposed to include warnings about "liver damage if consumers exceed the recommended dose, combine use with excessive consumption of alcohol" or if consumers "are allergic to the active ingredient."
The 100-count bottles labeled with National Drug Code (NDC) 50090-5350-0 were packed inside white pill bottles within a clear plastic bag as part of Health Essentials Kits.
The kits, which included other seasonal products such as Halls cough drops, were "distributed by Humana to its members," according to the FDA.
The affected bottles were "likely" distributed nationwide between Jan. 14, 2021, and March 15, 2021. The expiration dates are either July 31, 2022, or Aug. 31, 2022.
The company is not aware of any reports of "adverse events" related to the recalled product. However, the agency said the affected bottles, which lack "the full OTC Drug Facts chart," should be returned.
ASM or its distributors will provide pre-addressed return mailers for customers, the FDA said.