AstraZeneca Pharmaceuticals LP is recalling 18,056 bottles of Lynparza (olaparib) 50 mg capsules because the medication failed to meet quality specifications for impurities and degradation. Specifically, testing found elevated levels of a certain crystal form of the drug (Form L polymorph), which can affect how the medication performs. This recall affects 112-count bottles distributed nationwide that were manufactured for Astra Zeneca by Patheon Pharmaceuticals.
The presence of elevated impurities or changes in the drug's crystalline structure (polymorphism) can potentially alter the way the medication is absorbed or how stable it remains over time. This could result in the patient receiving a different dose than intended or an ineffective treatment.
Consultation and Refund
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Sources: FDA iRES · Raw API Response
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