Reported Mar 14, 2018 · Terminated

Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra Zeneca Pharmaceuticals LP…

AstraZeneca Pharmaceuticals LP

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: AstraZeneca Pharmaceuticals LP · 1800 Concord Pike · Wilmington, DE · 19897-0001

Is this the product you have?

    • Lynparza (olaparib) capsules 50 mg
    • 112 count bottles
    • Rx only
  • Manufactured forAstra Zeneca Pharmaceuticals LP Wilmington
  • DE 19850 byPatheon Pharmaceuticals, Inc. Cincinnati OH 45237 Product of Switzerland NDC 0310-0657-58
Lot codes and dates
    • HN0406
    • 02/2018
    • JH0341
    • 03/2018
    • JH0342
    • 03/2018
    • JH0147
    • 03/2018
    • JC0391
    • 04/2018
    • JK0147
    • 04/2018
    • JL0184
    • 04/2018
    • JC0402
    • 05/2018
Amount recalled
18056 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 26, 2019 · Data as of Sep 19, 7:16 PM UTC

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