Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
What was recalled
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
- Recalling firm
- AstraZeneca Pharmaceuticals LP
- NDC code
- 0310-0657-58
- Origin
- DE, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0585-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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