January 21, 2015
By Jessica Wilson, BioSpace.com Breaking News Staff
Two of the world’s best-known biopharma companies, Actavis plc and Aurobindo, are recalling anticonvulsant and analgesic Gabapentin capsules, because they were manufactured at faulty facilities in India.
The drug company Aurobindo Pharma is recalling 24,816 bottles of Gabapentin capsules according to India’s Economic Times. The Times reported that the U.S. Food and Drug Administration (FDA) stated the reason for the recall as “complaints of empty capsules received.” The Gabapentin capsules were manufactured by Aurobindo Pharma at its Mahabub Nagar facility in Andhra Pradesh, India.
Bottles of the same capsule type, but with different strengths, manufactured by Actavis Pharma are also being recalled in Puerto Rico. This recall involves 64,719 bottles manufactured in the Actavis Pharma facility in Kanchipuram, India. Actavis Elizabeth distributed the capsules that caused the complaints, which included clumping and breaking of capsules. Aurobindo has initiated a Class II recall in the U.S., which the US FDA defines as, “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
When Aurobindo announced the recall in November 2014, the company stated, “Empty capsules could result in missed dose(s) of gabapentin 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.” The company also noted that it had “not received any reports of adverse events related to this recall to date,” but it had “received four complaints for empty capsules.”
Aurobindo released the following specifics about the recalled capsules, “The affected Gabapentin lot is GESB14011-A, Expiration 12/2015 and is packaged in 100-count bottles, NDC 16714-662-01. The product can be identified by the imprint D on yellow cap and 03 on yellow body with black edible ink. Product was distributed through Northstar label to retail outlets nationwide.”
The Actavis Pharma recall of Gabapentin is actually three different recalls, as reported by DNA India. The first recall involved 29,622 bottles of 100 mg Gabapentin capsules in 100 capsules per bottle with an expiration date of October 2015, and in 500 capsules per bottle with an expiration date of March 2016. The second recall was for 24,240 bottles of 300 mg capsules bottled at 100 capsules per bottle with an expiration date of one lot in September 2015 and the other in October 2015. The third recall was for 10,857 bottles of 400 mg Gabapentin capsules in 100 capsules per bottle with an expiration date of June 2015 and in 500 capsules per bottle with an expiration of August 2015.
The reason for the recalls was the same. “Actavis has received several complaints for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center,” reported DNA India.
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