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FDA AND OTHER REGULATORY UPDATES
Voluntary Recall of Specific Batch of Gabapentin 300 mg Capsules
November 25, 2014
The FDA recently announced the voluntary recalling of Gabapentin 300 mg capsules from lot GESB14011-A in 100-count bottles by the company Aurobindo Pharma USA. The company found that the product included some empty capsules. Patients with seizures taking these capsules would receive no antiseizure medication, and could experience breakthrough seizures, medication withdrawal events, and medical emergencies. The FDA has issued a warning stating that patients should check their Gabapentin 300 mg, and if it matches the described lot number and the manufacturer, should contact their pharmacist for help in replacing the medication. Patients experiencing changes in seizures or other symptoms should contact their health care practitioner for immediate assistance.