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

Recall Number: D-0585-2018

Firm: AstraZeneca Pharmaceuticals LP

Classification: Class III

Status: Terminated

Report Date: 20180314

Initiation Date: 20180223

Termination Date: 20190226

Reason for Recall

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

Product Description

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