The capsules were manufactured at two plants in India
Indian generics manufacturer Aurobindo Pharma is recalling 24,816 bottles of Gabapentin capsules used as an anticonvulsant and analgesic following complaints of empty capsules in the US market.
According to the US Food and Drug Administration (FDA), the Indian firm's Aurobindo Pharma USA arm has initiated a Class II nationwide recall. Each bottle contains 100 capsules of 300mg capsules. The drug is manufactured by Aurobindo Pharma at its Mahabub Nagar facility in Andhra Pradesh.
The US FDA initiates a Class II recall where use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences. The FDA initiated this recall because of complaints about empty capsules.
In another development, a total of 64,719 bottles of different strengths of the same capsule manufactured by Actavis Pharma at its Kanchipuram facility were also being recalled in Puerto Rico. The capsules were distributed by Actavis Elizabeth and were recalled following several complaints about clumping and breaking of capsules and creased labels from one distribution centre.