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Recall Observatory FDA recall evidence

Drug product

Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra Zeneca Pharmaceuticals LP Wilmington, DE 19850 by: Patheon Pharmaceuticals, Inc. Cincinnati OH 45237 Product of Switzerland NDC 0310-0657-58

D-0585-2018

February 23, 2018

Class III

Product summary

Firm
AstraZeneca Pharmaceuticals LP
Event
Event 79290
Status
Terminated
Classification
Class III
Quantity
18056 bottles
Official record key
drug-enforcement:D-0585-2018

Official wording

Reason: Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).

Code information: HN0406 02/2018 JH0341 03/2018 JH0342 03/2018 JH0147 03/2018 JC0391 04/2018 JK0147 04/2018 JL0184 04/2018 JC0402 05/2018

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications