New Delhi: Drug firm Aurobindo Pharma is recalling 24,816 bottles of Gabapentin capsules used as anticonvulsant and analgesic following complaints of empty capsules in the US market.
According to notification by the US Food and Drug Administration (USFDA), the Indian firm's arm Aurobindo Pharma USA Inc has initiated a Class II nation wide recall. Each bottle contains 100 capsules of 300 mg.
The drug is manufactured by Aurobindo Pharma at its Mahabub Nagar facility in Andhra Pradesh.
As per the US Food and Drug Administration (USFDA) a Class II recall is initiated in a situation under which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences.
The reason for the recall, as per USFDA, was that "complaints of empty capsules received".
In another development, a total of 64,719 bottles of different strengths of the same capsule manufactured by Actavis Pharma Manufacturing Pvt Ltd at Kanchipuram facility were being recalled in Puerto Rico.
The capsules were distributed by Actavis Elizabeth LLC and were being recalled following several complaints, including clumping and breaking of capsules and creased labels from one distribution centre.
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