The Recall Desk
LowFDA (Drugs)·D-0585-2018·Announced 2018-03-14

AstraZeneca Recalls Lynparza Capsules Due to Quality Attribute Deviation

AstraZeneca is recalling 18,056 bottles of Lynparza (olaparib) capsules 50 mg due to elevated levels of a specific quality attribute.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

AstraZeneca Pharmaceuticals LP is recalling 18,056 bottles of Lynparza (olaparib) capsules 50 mg, 112 count bottles. The recall is being conducted because the product failed impurities and degradation specifications, specifically showing elevated levels of the quality attribute Form L (polymorph).

The affected product is prescription-only and was distributed nationwide. The recall covers specific lot codes including HN0406, JH0341, JH0342, JH0147, JC0391, JK0147, JL0184, and JC0402, with expiration dates ranging from February 2018 to May 2018.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

The recalled product

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
Manufacturer
AstraZeneca Pharmaceuticals LP
Category
Drug — Oncology
Hazard
Affected units
18,056

Distribution

Distributed nationwide across the United States.

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