February 2018 FDA Recall Drug by Astrazeneca Pharmaceuticals Lp (D-0585-2018 - Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).)

This Class III drug recall was voluntarily initiated by Astrazeneca Pharmaceuticals Lp on February 23, 2018 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications; elevated levels of quality attribute form l (polymorph).. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0585-2018

Reason for Recall
Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
Initiated
02-23-2018
Reported
03-14-2018
Quantity
18056 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79290
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AstraZeneca Pharmaceuticals LP
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-26-2019
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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