AstraZeneca Pharmaceuticals LP

FDA Regulatory Profile

Summary

Total Recalls
6 (1 Class I)
510(k) Clearances
0
Inspections
61
Compliance Actions
1

Known Names

astrazeneca pharmaceuticals, astrazeneca pharmaceuticals co

Recent Recalls

NumberClassProductDate
D-0028-2026Class IIFasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, ManufactureOctober 8, 2025
D-0585-2018Class IIILynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra Zeneca PharmFebruary 23, 2018
D-0958-2017Class IBRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx only, Mfd. for: AstraZMay 25, 2017
D-0781-2016Class IITudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses peFebruary 5, 2016
D-1141-2015Class IINEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count bottle, Rx only, ManufacJune 10, 2015
D-840-2013Class IIMERREM I.V. (meropenem for injection), 1 g meropenem equivalent, 30 mL vial, Rx only, Mfd for: AstraJune 21, 2013