AstraZeneca Pharmaceuticals LP

Complete recall history across all FDA and CPSC categories — 4 total recalls

AstraZeneca Pharmaceuticals LP appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (4)

FDA drug safety enforcement actions by AstraZeneca Pharmaceuticals LP

Date Product Reason Class
Feb 23, 2018 Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured ... Failed Impurities/Degradation Specifications; elevated levels of quality attr... Class III
Feb 5, 2016 Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuati... Defective Delivery System: Some units have actuation counters set to a number... Class II
Jun 10, 2015 NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count b... Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail... Class II
Jun 21, 2013 MERREM I.V. (meropenem for injection), 1 g meropenem equivalent, 30 mL vial, ... Presence of Precipitate; potential for incomplete constitution upon addition ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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