Safety Alerts & Recalls

What does this mean?

This safety alert should be taken seriously as empty capsules could result in missed dose(s) of gabapentin and may cause adverse health effects. These effects could range from a short-term decrease in effectiveness, short-term withdrawal effect, or a long period of seizures that could be life threatening.

Please check your prescription bottles to see if you have gabapentin 300 mg capsules from lot GESB14011-A made by Aurobindo and distributed by Northstar Rx. If you think you have the gabapentin capsules involved in the recall, please follow up with your pharmacist immediately to get a replacement supply. If your pharmacist has repackaged your prescription into a pharmacy bottle and you are not sure who made your capsules or can’t find the lot number, please follow up with your pharmacist who can determine if your capsules are involved in the recall.

Please contact your doctor or healthcare provider if you have experienced any problems that you think may be related to taking any capsules from this recalled lot of gabapentin or if you have other questions about your medicine.

If you have questions regarding this recall, you can also call Aurobindo Pharma USA Pharmacovigilance group at (732) 839-9400 Option 2 (8:30 AM to 5:00 PM ET, Monday through Friday) or send an email to: PVG@aurobindousa.com.

Patients and healthcare providers are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:

--- Telephone: 1-800-332-1088

--- Fax: 1-800-332-0178

--- Mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

--- Website: http://www.fda.gov/Safety/MedWatch/default.htm

Empty Gabapentin 300 mg Capsules From Aurobindo Pharma Prompt Recall

Aurobindo Pharma USA is voluntarily recalling a single lot of gabapentin capsules 300 mg in 100-count bottles. The affected lot number is GESB14011-A with an expiration date of 12/2015 and has NDC 16714-662-01 on the label. Bottles in this lot have been found to contain some empty capsules. The recalled product was manufactured by Aurobindo Pharma Limited and was distributed with a Northstar Rx label to retail outlets nationwide.

Gabapentin is commonly used in the treatment of epilepsy and for the management of postherpetic neuralgia (pain after shingles). Gabapentin is available from many generic manufacturers and under the brand name Neurontin. Gabapentin is also available in other capsule strengths. This recall alert only affects gabapentin 300 mg capsules from lot GESB14011-A made by Aurobindo and distributed by Northstar Rx.

For more information, please visit: more information here

To view a photograph of the original packaging and labeling, please visit: more information here

Source: FDA
Publication Date: 2014-11-25
Last Updated: 2014-11-25

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