On November 21, 2014, the pharmaceutical company Aurobindo Pharma USA announced its voluntary recall of a particular lot (GESB14011-A, expiration date 12/2015) of its Gabapentin Capsules, USP 300 mg 100-count bottles because the lot has been found to contain some empty capsules. The capsules have an imprinted D on yellow cap and 03 on yellow body with black edible ink, which were distributed through the Northstar label to retail outlets throughout the United States.
What Is Gabapentin?
Gabapentin is an anticonvulsant medication used to help control certain types of seizures in people who have epilepsy by decreasing abnormal excitement in the brain, as well as to relieve the pain of postherpetic neuralgia (the burning, stabbing pain or aches that may last for months or years after an attack of shingles) by changing the way the body senses pain. Gabapentin extended-release tablets are used to treat restless legs syndrome (a condition that causes discomfort in the legs and a strong urge to move the legs, especially at night and when sitting or lying down).
Some serious side effects of Gabapentin may include rash, itching, swelling of the face, throat, tongue, lips, or eyes, hoarseness, difficulty swallowing or breathing, and seizures. Other less serious side effects may include drowsiness, tiredness or weakness, dizziness, headache, uncontrollable shaking of a part of the body, double or blurred vision, unsteadiness, anxiety, memory problems, strange or unusual thoughts, unwanted eye movements, nausea, vomiting, heartburn, diarrhea, dry mouth, constipation, increased appetite, weight gain, swelling of the hands, feet, ankles, or lower legs, back or joint pain, fever, runny nose, sneezing, cough, sore throat, or flu-like symptoms, ear pain, and red, itchy eyes (sometimes with swelling or discharge).
The Dangers Of Empty Gabapentin Capsules
Aurobindo Pharma USA warns that empty Gabapentin capsules could result in missed dose(s) resulting in adverse health consequences that could range from no effect, short term reduction in efficacy, short term withdrawal effect, or status epilepticus (long period seizures) that could be life-threatening. Aurobindo Pharma USA reports that it has not received any reports of adverse events related to the recall but has received four complaints for empty capsules.
Aurobindo Pharma USA has provided generic pharmaceuticals to pharmacists and patients in the United States since 2004, and currently has more than 125 product families and 450 individual product packages. Aurobindo Pharma USA was one of the top ten pharmaceutical companies, brand or generic, in terms of total prescriptions dispensed in 2013. Aurobindo Pharma USA operates two facilities in the United States, both of which are located in central New Jersey.
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