The European Medicines Agency has given its OK for a precautionary recall of Astellas Pharma's ($ALPMY) Advagraf 0.5-mg capsules, citing the presence of more API than is standard. The 12-batch recall was issued to EU pharmacies and wholesalers.
The defect was detected during routine testing by the Japanese drugmaker, according to an EMA announcement. The company found that an average of 70% of the capsules' API, tacrolimus, was released during the first 1.5 hours of dissolution testing. The specified range is 48% to 68%.
Excess API can be a sign of production processes that are not well controlled, according to the FDA. It was among the GMP violations cited last year in a warning letter to Sunshine Pharmaceutical--now 3SBio ($SSRX).
The drug is formulated as prolonged-release hard capsules. The affected batches were distributed across the EU, with the greatest concentrations of remaining stock in the U.K. and Romania.
The recall is not expected to affect availability of Advagraf, which is used to prevent organ rejection in transplant patients. Astellas has replacement batches available.
- here's the announcement
- see this story
* Correction: Astellas points out that the recall was based on too high a release of the active ingredient during a specific phase of dissolution, and not excess API, as originally reported. The article and headline have been corrected.