AstraZeneca is recalling batches of Lynparza (olaparib) 50 mg capsules as the level of olaparib polymorphic form L exceeds or could exceed, the registered specification limit.
The manufacturer has issued a recall on batch number NG327, which was initially distributed on 13 October 2017. As a precautionary measure, another 6 batches are also being recalled as they may exceed the limit before the end of the shelf life – Batch numbers NG143, NK719, NJ972, NR730, NK591 and NR497. All affected batches were first distributed between July and December 2017 and have expiry dates falling between April and November 2018.
Olaparib, the active ingredient in Lynparza capsules, can exist in 2 crystalline polymorphic forms, Form A and Form L. Form A is more soluble than Form L and is the preferred polymorphic form. During regular medicinal product monitoring, raised levels of Form L were detected in 1 batch of Lynparza 50 mg capsules and exceeded the registered specification limit of 10%. Although the level of Form L exceeded the registered specification limit, it is below the 20% threshold considered to have a potential clinical effect of efficacy by lowering solubility.
Healthcare providers are advised to stop using and dispensing the batches listed. All remaining stock of these batches should be returned to the supplier.