D-0585-2018 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 14, 2018
- Initiation Date
- February 23, 2018
- Termination Date
- February 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18056 bottles
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
Reason for Recall
Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
Distribution Pattern
Nationwide
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