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drug recall
A popular painkiller was recalled due to a rather unusual problem with the packaging. Everyone in the United States is familiar with the “Facts about medications” label included with all over-the-counter medications. It explains how to use the medicine and what to avoid, including dosage limits and the time for subsequent doses. Unfortunately, nearly 200,000 vials of paracetamol in 500 mg tablets have been removed due to the fact that the drug label does not include the required Medication Facts section.
The medicine was part of a “Basic Health Kit” that was distributed to Humana members. The drugs were manufactured by AS Medication Solutions, LLM, and were distributed in bottles of 100 units. In total, 198,350 vials of the painkiller were given to Humana members as part of their kits and now the drug must be returned.
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It is an interesting reminder because, according to the bulletin, there does not seem to be anything really wrong with the medication itself. The problem is that anyone who uses the drug may not have all the facts available that they need to use it safely, which is enough for the FDA to issue a recall alert and, hopefully, help the company collect all the medicines distributed.
However, this will be a challenge, as there are almost 200,000 vials of the drug and it was distributed over a period of two months, from 1/14/21 to 3/15/21. The expiration dates for the vials are 07/31/22 or 08/31/22.
The recall bulletin says, in part:
Paracetamol use can be potentially harmful if the safety warnings on the OTC label are not observed, including: liver damage if consumers exceed the recommended dose, combine use with excessive alcohol consumption or are allergic to the active ingredient . To date, the Company has not received any reports of adverse events related to this recall.
If you have any of this medication from one of the Health Essentials kits distributed by Humana, you can contact the manufacturer using the information on the recall bulletin page. The company is arranging for the drug to be collected by post and will provide pre-addressed return packages to facilitate shipping.
The company claims to have received “no reports of adverse events” related to the recall, which makes sense, since most people who take paracetamol are probably familiar with the drug and are taking it as instructed. However, proper documentation should be included in the bottles or packaging if someone is not used to taking them and may not be aware of the potential side effects and other important information.
You can also find a list of lot numbers and other identification marks on the recall page, which will help you locate the drugs being recalled and recover your money if you have purchased one.
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