Aurobindo, one manufacturer of generic gabapentin, has issued a voluntary recall of one lot of gabpentin capsules. Gabapentin (brand name Neurontin) is most commonly used to treat nerve pain, especially in diabetic patients with neuropathy, and seizure disorders.
This is a Class I recall, which means there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. Class I recalls are the most serious; Class II and III are both more common and mean the affected drug is less likely to cause adverse effects.
Why were the gabapentin capsules recalled?
The affected lot of gabapentin was found to contain some empty capsules. An empty capsule would mean a missed dose, which could result in decreased effectiveness, short-term withdrawal, or seizure (if you’re using gabapentin to prevent them).
Which products are affected?
In this recall only one manufacturer and one lot were affected:
Drug: gabapentin 300 mg capsules, 100-count bottle
Manufacturer: Aurobindo Pharma USA (Northstar Rx LLC)
Expiration date: 12/2015
National Drug Code (NDC): 16714-662-01
You can also see the packaging of the affected product here.
What is being done about the recall?
Aurobindo Pharma USA is notifying its distributors and customers using recall letters. They are arranging for a return of all recalled medication.
Many pharmacies are also placing calls to patients who have received the affected gabapentin 300 mg capsules within a certain date range.
How do I reach Aurobindo if I have questions?
You can contact the manufacturer via telephone or email with any questions regarding the recall.
You can call the Aurobindo Pharmacovigilance group at (732) 839-9400, option 2, Monday through Friday between 8:30 am and 5:00 pm, EST, or contact them via email at PVG@aurobindousa.com.
You can also find more information in the full FDA announcement here.