IGMPI India



Gabapentin Capsules recalled by Aurobindo and Actavis

Following complaints of empty capsules in the US market, drug firm Aurobindo Pharma is recalling 24,816 bottles of Gabapentin capsules used as anticonvulsant and analgesic. A Class II nationwide recall was initiated by the Indian firm's arm Aurobindo Pharma USA Inc. based on a notification by the US Food and Drug Administration (USFDA). Each bottle contains 100 capsules of 300 mg.Manufacturingof the drug takes place by Aurobindo Pharma at its Mahabub Nagar facility in Andhra Pradesh.

As per US FDA this type of recall procedure is initiated in response to the situations under which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences. As per the US FDA the recall was because complaints were received about empty capsules. Besides this, a recent recall in Puerto Rico, of 64,719 bottles of different strengths of the same capsule manufactured by Actavis Pharma Manufacturing Pvt. Ltd. at Kanchipuram facility.

Distribution of these capsules was done by Actavis Elizabeth LLC and was recalled on account of several complaints, including clumping and breaking of capsules and creased labels from one distribution centre.