Indian Drugmaker Recalls Anti-Seizure Product Due to Empty Capsules
Aurobindo Pharma is pulling 24,160 bottles of its anticonvulsant gabapentin because some of the drug capsules don’t contain any product.
The recall, initiated by the India-based drugmaker, was deemed Class II by the FDA, meaning it could cause temporary health problems but the probability of a serious adverse event is remote, according to a recent FDA enforcement report.
Subpotent drugs are a common cause of recalls, contributing to 22 recalls last year out of a total of 337 events. However, drugs that aren’t potent at all due to empty capsules is rare and hasn’t been cited as a reason for recalls in the past two years.
Gabapentin is an anticonvulsant prescribed to treat seizures and to relieve pain associated with damaged tissue.
Meanwhile, Actavis is in the midst of a recall of the same product for a different problem. The Irish drugmaker is pulling approximately 2,000 bottles of different dosages of gabapentin shipped to a specific customer due to complaints of clumping and breaking capsules, spokesman David Belian said.
Actavis also received reports that the bottom of the bottle was popped out, an FDA enforcement report said.
Aurobindo did not return a request for comment by press time.
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