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 overview 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 two lots of amphetamine salts 10 mg tablets.
Why are the amphetamine salt tablets recalled?
The recall is based on the discovery that the affected lots of both medications did not meet FDA regulatory requirements for blend uniformity specification. This means that the tablets can differ greatly from each other from one lot to the next, which is not acceptable by either FDA or manufacturing standards.
When was the recall initiated?
The affected lots of amphetamine salts were recalled by the manufacturer on June 25, 2015.
How long have the affected products been in pharmacies?
The recalled lots of amphetamine salts 10 mg tablets started shipping almost two years ago, on July 22, 2013.
Are patients being notified who have taken either of these medications?
No. This is a class II recall, which means that notification of patients is not necessary unless your doctor believes it may have an effect on your health.
If you have concerns that your prescription may be affected, contact your doctor or your pharmacist.
Which products were affected?
In this recall, two lots and one strength were affected.
Drug:amphetamine salts 10 mg tablets, 100-count bottle
• 24015862A, expiration: 06/2016
• 34016376A, expiration: 7/2016
National Drug Code (NDC): 60505-0209-01