Drug recall D-0585-2018

Class III Terminated reported Mar 14, 2018

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

Reason for recall

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

Lots and codes

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

Recall details

Recalling firm
AstraZeneca Pharmaceuticals LP, Wilmington, DE
Quantity
18056 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
February 23, 2018
Terminated
February 26, 2019