Astrazeneca Lp Product Recalls

Lynparza (AstraZeneca) – Elevated Impurity (2018)

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

Class IIILow

FDAFeb 23, 2018Nationwide• AstraZeneca Pharmaceuticals LP

BRILINTA Tablets (AstraZeneca) – Foreign Tablets (2017)

Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.

Class IHigh

FDAMay 25, 2017Nationwide• AstraZeneca Pharmaceuticals, LP

Tudorza Pressair (AstraZeneca) – Defective Counter (2016)

Defective Delivery System: Some units have actuation counters set to a number other than 60.

Stay Informed

AstraZeneca Pharmaceuticals LP Recalls

Recall Summary

Lynparza (AstraZeneca) – Elevated Impurity (2018)

BRILINTA Tablets (AstraZeneca) – Foreign Tablets (2017)

Tudorza Pressair (AstraZeneca) – Defective Counter (2016)

NEXIUM Capsules (AstraZeneca) – foreign tablets (2015)

Merrem IV Injection (AstraZeneca) – Precipitate Concern (2013)

Pulmicort Respules 0.25mg (AstraZeneca) – Specification Range (2013)

Pulmicort Respules 0.5mg (AstraZeneca) – Specification Range (2013)