FDA recall D-0585-2018

Product

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2018-02-23

Report date

2018-03-14

Termination date

2019-02-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wilmington, DE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0585-2018