AstraZeneca Pharmaceuticals LP recalls Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra Zeneca Pharmaceuticals LP Wilmi…
- Recall date
- February 23, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0585-2018
- FDA classification
- Class III
- Brand / firm
- AstraZeneca Pharmaceuticals LP
- Sold / distributed
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
Class III means the product violates regulations but is not likely to cause harm.
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
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