D-0585-2018 Class III Terminated
FDA drug recall D-0585-2018 was initiated by AstraZeneca Pharmaceuticals LP on Feb 23, 2018 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph). The recall status is terminated (terminated Feb 26, 2019). Affected quantity: 18056 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 14, 2018
- Initiation Date
- Feb 23, 2018
- Termination Date
- Feb 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0585-2018
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026