FDAFDA · Food and drugs·Recall number D-0585-2018
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
Published March 14, 2018 · Recall initiated: February 23, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AstraZeneca Pharmaceuticals LP
- Distributor
- Nationwide
- Lot
- HN0406 02/2018 JH0341 03/2018 JH0342 03/2018 JH0147 03/2018 JC0391 04/2018 JK0147 04/2018 JL0184 04/2018 JC0402 05/2018
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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