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Nearly 200,000 bottles of acetaminophen have been recalled, many of which were included in “health essential” kits distributed by Humana, according to a notice issued by the Food and Drug Administration (FDA).
Libertyville, IL, A-S Medication Solutions, LLM (ASM) failed to properly label the acetaminophen bottles contained in Health Essentials Kits distributed by Humana to its members, says the FDA notice, prompting the voluntary recall. The FDA notice includes 198,350 bottles of Acetaminophen Extra Strength 500 mg Tablets, 100 ct. in the recall.
“Use of acetaminophen could be potentially harmful if safety warnings contained on the [over-the-counter] label are not observed including: liver damage if consumers exceed the recommended dose, combine use with excessive consumption of alcohol, or are allergic to the active ingredient,” warns the FDA.
The notice goes on to state that the recalled acetaminophen was distributed in white, plastic, 100-count bottles labeled with NDC 50090-5350-0 and have an expiration date of either July 31, 2022 or Aug. 31, 2022. The bottles contain a short drug label but do not include a longer label that fully explains the risk of the pain killer.
The recalled bottles were included in a clear plastic bag with other seasonal products labeled as a “Health Essentials Kit,” which Humana distributed to its members between Jan. 14 and March 15 of this year, according to the recall notice.
Acetaminophen: Overdose Concerns
Acetaminophen, which is used in the brand name Tylenol, can pose serious risks in the event of an overdose. Taking too much of the pain killer can lead to liver damage and other problems, according to Healthline.
Additionally, the difference between taking the maximum recommended dose and too much acetaminophen is small, says Healthline. In fact, Tylenol and other drugmakers lowered their recommended maximum dose for the pain killer to address overdose issues.
Babies and small children, in particular, are at risk of serious complications if too much acetaminophen is administered. In addition, those who take warfarin, suffer from liver disease, or consume more than three alcoholic drinks in a day should be wary of the pain killer, says Healthline.
Symptoms of an acetaminophen overdose include:
- Stomach pain
- Nausea
- Vomiting
- Loss of appetite
Top Class Actions will continue to monitor this story to help keep consumers informed.
Have you received a Humana health kit with the recalled acetaminophen? Tell us about it in the comment section below.
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