Medicine Recall: Gabapentin 300-mg Capsules

by pharmacy on January 21, 2015

pillsPharmacies with NorthStar Rx 300-mg gabapentin capsule from lot GESB14011-A may notice that some of the boxes are empty. Even bottles that contain medicine may have empty capsules in them. The U.S. based subsidiary Aurobindo Pharma USA announced a voluntary recall in late November. The company says bottles in the lot entered the U.S. market in March 2014. Gabapentin is used to treat both epilepsy and postherpetic neuralgia, the management of pain after shingles.

Lot GESB14011-A expires in December 2015, and is packaged in 100-count bottles. The medication can be identified by looking for the letter D imprinted on a yellow capsule, and a “03” imprinted on the yellow body in black edible ink.

If your pharmacy has received any bottles from this lot, Aurobindo Pharma will be sending letters to both distributors and customers to arrange for the product to be returned. Any medication you may have from this lot should be set aside so it is not distributed to patients. Patients who already have this medication in hand should stop using it and return it to the place of purchase.

Distributing bottles with empty capsules to patients may result in missing doses, and a number of adverse health effects as a result. Patients could experience no effects, however it’s also possible they could experience a short term reduction if the efficacy of the medication, a short term withdrawal symptoms, or status epilepticus – long period, potentially life-threatening seizures.

So far, Aurobindo Pharma has not received any notification of adverse events, but has received a small number of complains about empty capsules in the bottles.

If there are any questions about this recall, consumers are encouraged to contact Aurobindo Pharma USA Pharmacovigilance group at (732) 839-9400, and select option 2. Customers can reach someone via phone Monday through Friday, 8:30 AM to 5:00 PM EST. They can also be reached via email at: PVC@aurobindousa.com.

Customers experiencing problems that may be a result of the missed medicine doses should see their physician or other healthcare provider. Quality problems or adverse reactions can be reported to the FDA’s MedWatch Adverse Event Reporting program online, by mail, or by fax.

To complete and submit the report online, visit: www.fda.gov/medwatch/report.htm.

To complete the form by mail, visit: www.fda.gov/MedWatch/getforms.htm. Download and print the form, then mail to:

MedWatch

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857

Alternatively, you can call 1-800-332-1088 to request a copy of the reporting form. Completed forms can also be faxed to 1-800-332-0178. Pharmacy staff should remain available to consumers who require assistance completing the form.

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