Mutual Pharmaceuticals has issued a voluntary recall of several lots of ergoloid mesylates 1 mg tablets. Ergoloid mesylates are indicated for the treatment of patients who show signs and symptoms of decline in mental ability including skills of daily living, mood, self-care, or motivation, particularly patients with dementia or Alzheimer’s disease.
This is a class II recall, the most common type of recall, which means that there is a situation where use of the recalled product may cause temporary or medically reversible adverse health consequences, but the probability of serious adverse effects is remote. For more information on the different types of recalls, see our previous post here.
Who can recall a drug?
The manufacturer can voluntarily recall their medication or the Food and Drug Administration (FDA) can request or require that a manufacturer recall a particular medication. In this case, the manufacturer has voluntarily recalled some lots of ergoloid mesylates 1 mg tablets, and the FDA is aware of the recall.
When was the recall initiated?
The affected lots of ergoloid mesylates 1mg tablets were recalled on March 10, 2015
How many total bottles were affected?
There were 23,246 bottles recalled, which were distributed between the months of July 2012 and March 2015.
Are patients who take this medication being notified?
No. This a class II recall, which means that notification of patients is not necessary unless deemed so by clinical judgment—unless your doctor believes it may have an effect on your health.
How else might this affect you?
In some cases, pharmacies may not currently have this medication in stock due to the recall.
Why were the tablets recalled?
The affected lots of ergoloid mesylates 1 mg tablets were recalled based on stability results. This could cause decreased efficacy due to an inadequate or low potency dose.
Which products were affected?
In this recall only one manufacturer and five different lots were affected.
Drug: ergoloid mesylate 1 mg tablets, 100-count bottle
Manufacturer: Mutual Pharmaceuticals (Sun Pharmaceutical Industries)
• 6557301, expiration: 03/2015
• 6557401, expiration: 03/2015
• 6557501, expiration: 03/2015
• 6656301, expiration: 10/2016
• 6687701, expiration: 04/2017
National Drug Code (NDC): 53489-0281-01