Class III
Terminated
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
This recall has been terminated (originally issued March 14, 2018).
- Company
- Astrazeneca Pharmaceuticals Lp
- Recall Initiated
- February 23, 2018
- Posted
- March 14, 2018
- Recall Number
- D-0585-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 18056 bottles
- Firm Location
- Wilmington, DE, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
Distribution
Nationwide
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
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