Recalls / Class III
Class IIID-0585-2018
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
- Affected lot / code info
- HN0406 02/2018 JH0341 03/2018 JH0342 03/2018 JH0147 03/2018 JC0391 04/2018 JK0147 04/2018 JL0184 04/2018 JC0402 05/2018
Why it was recalled
Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
Recalling firm
- Firm
- AstraZeneca Pharmaceuticals LP
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1800 Concord Pike, N/A, Wilmington, Delaware 19897-0001
Distribution
- Quantity
- 18056 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-02-23
- FDA classified
- 2018-03-09
- Posted by FDA
- 2018-03-14
- Terminated
- 2019-02-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0585-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.