Actavis pulls Patheon-made diabetes pills after out-of-spec tests

By Gareth Macdonald contact

- Last updated on GMT


Related tags: Food and drug administration, Generic drug

Actavis has recalled five lots of a diabetes drug glipizide made by Patheon after tests revealed that the tablets did not meet specifications.

The recall – which is detailed in a US Food and Drug Administration FDA) enforcement report​ – involves 167,152 bottles of the generic blood sugar control medicine that were made by Patheon at its facility in Cincinnati, Ohio.

Actavis – which was sold by Allergan to Teva this month​ - said the pills had failed dissolution tests, but did not provide additional information.

Newly public contract manufacturing organisation (CMO) Patheon told this publication the recall was related to the use of a new larger pill bottle.

A spokeswoman told us “A joint review of the product by the client and Patheon determined that the dissolution of the product was impacted by the increase in the bottle size and addition of a desiccant.

"The client initiated a voluntary recall. The client switched back to the previous packaging configuration and Patheon resumed production of the product in July.​"

According to Patheon, Actavis has switched back to the original packaging, which does not require use of a desiccant.

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