If a patient was to receive a sub potent tablet, symptoms may not be controlled.To date, there have been no reports of adverse events related to this recall.The recalled products were distributed nationwide in the USA to hospitals/clinics.
Loperamide is FDA-approved to help control symptoms of diarrhea, including Travelers Diarrhea.
The maximum approved daily dose for adults is 8 mg per day for OTC use and 16 mg per day for prescription use.
Customers that have any of the affected medications that are being recalled should immediately quarantine the product, discontinue use and destroy per their hospital protocol.
Customers with any of the affected medications can also reference Phar MEDium Services website for more information on the specific lot numbers affected and contact information:
It is safe at approved doses, but when much higher than recommended doses are taken, it can lead to serious problems, including severe heart rhythm problems and death.
FDA is continuing to evaluate this safety issue and will update the public when more information is available.
Seek medical attention immediately by calling 911 if you or someone taking loperamide experiences any of the following, and tell health care professionals the person has been taking loperamide: Fainting Rapid heartbeat or irregular heart rhythm Unresponsiveness, meaning that you cant wake the person up or the person doesnt answer or react normally Health care professionals should be aware that using much higher than recommended doses of loperamide, either intentionally or unintentionally, can result in serious cardiac adverse events, including QT interval prolongation, Torsades de Pointes or other ventricular arrhythmias, syncope, and cardiac arrest.
In cases of abuse, individuals often use other drugs together with loperamide in attempts to increase its absorption and penetration across the blood-brain barrier, inhibit loperamide metabolism, and enhance its euphoric effects.
Patients and consumers should only take the dose of loperamide directed by your health care professionals or according to the OTC Drug Facts label, as taking more than prescribed or listed on the label can cause severe heart rhythm problems or death.
If you are using OTC loperamide and your diarrhea lasts more than 2 days, stop taking the medicine and contact your health care professional.
It is sold under the OTC brand name Imodium A-D, as store brands, and as generics.