Mumbai-based Sun pulled two lots nimodipine – previously sold by its US subsidiary Caraco -after quality tests showed the drug’s active ingredient had crystalized within the capsules.
Sun told the US Food and Drug Administration (FDA) the withdrawal, which was prompted by a complaint, was a precautionary move and that the “product may no longer be bioequivalent and may potentially affect patients who are being treated for a medical emergency.”
The Indian firm also named Maryland-based Pii as the contract manufacturing organisation (CMO) that made the drug on its behalf.
Pii – which is adding capacity at the manufacturing site where the affected nimodipine was produced – has not yet issued a statement on the recall.
The news will be a bitter pill – or capsule - for Sun, which last week finally seemed to be making some progress in addressing the long-running regulatory difficulties it faced in the US.
In a statement issued on August 28, Sun announced that the FDA had given the OK for production of certain drugs to resume at two Caraco sites in Michigan that were issued with a consent decree in 2009 following a number of quality concerns.
Sun said that the FDA – which is yet to post any corroboration of the information or close out letter on its website – “has notified [it] that Caraco may resume operations at its manufacturing facility and packaging sites in Detriot and Wixom, Michigan.
“During their inspection, the USFDA reviewed the certification reports for production of Carvedilol USP as well as Paramomycin USP, and subsequently reviewed corrective actions on 483's. Currently, Caraco may resume production of only these two products.”
The nimodipine recall also comes as Sun faces yet another hurdle in its long-running battle to buy Israeli drugmaker Taro Pharmaceuticals.