Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra Zeneca Ph...

FDA Drug Recall #D-0585-2018 — Class III — February 23, 2018

Recall Summary

Recall Number D-0585-2018
Classification Class III — Low risk
Date Initiated February 23, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm AstraZeneca Pharmaceuticals LP
Location Wilmington, DE
Product Type Drugs
Quantity 18056 bottles

Product Description

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 Pattern

Nationwide

Lot / Code Information

HN0406 02/2018 JH0341 03/2018 JH0342 03/2018 JH0147 03/2018 JC0391 04/2018 JK0147 04/2018 JL0184 04/2018 JC0402 05/2018

Other Recalls from AstraZeneca Pharmaceuticals LP

Recall # Classification Product Date
D-0781-2016 Class II Tudorza Pressair (aclindinium bromide inhalatio... Feb 5, 2016
D-1141-2015 Class II NEXIUM¿ (esomeprazole magnesium), Delayed-Relea... Jun 10, 2015
D-840-2013 Class II MERREM I.V. (meropenem for injection), 1 g mero... Jun 21, 2013

Frequently Asked Questions

Nitrosamines are probable human carcinogens — they can increase cancer risk with long-term exposure above certain thresholds, but they do not cause immediate harm from taking a single dose. The FDA calculates an acceptable daily intake (ADI) for each nitrosamine compound, and recalls are triggered when levels exceed this threshold. If you have been taking a recalled product, the FDA generally advises against abruptly stopping your medication (especially for critical conditions like blood pressure or diabetes) until you consult your doctor. The incremental cancer risk from short-term exposure is very small.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.