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
Product summary
- 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
Failed Impurities/Degradation Specifications