Sanofi-Aventis U.S. LLC: 16 recalls on record

Recalls filed with 1 agency: FDA (16).

First recall on record: June 1, 2016. Most recent: May 24, 2023.

Risk classification: Class I: 2 · Class II: 10 · Class III: 4

Most recent recalls

DateAgencyProduct
May 24, 2023FDAAdmelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sa…D-0575-2023
August 26, 2020FDAElitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. L…D-1507-2020
December 11, 2019FDARegular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2…D-0535-2020
December 11, 2019FDARegular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2…D-0540-2020
December 11, 2019FDACool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a …D-0534-2020
December 11, 2019FDAZantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga…D-0544-2020
December 11, 2019FDARegular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2…D-0542-2020
December 11, 2019FDAMaximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2…D-0536-2020
July 18, 2018FDAAdmelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in…D-0925-2018
May 9, 2018FDADocetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business o…D-0804-2018
January 17, 2018FDAEnoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx …D-0153-2018
November 8, 2017FDAClofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmach…D-0056-2018
July 5, 2017FDAGaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tabl…D-0926-2017
May 17, 2017FDAMozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx Only, Manufa…D-0704-2017
June 1, 2016FDAAuvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors…D-0873-2016
June 1, 2016FDAAuvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors …D-0872-2016

Questions about this company

How many recalls does Sanofi-Aventis U.S. LLC have?
Recalert has 16 U.S. recalls on record for Sanofi-Aventis U.S. LLC, published between June 1, 2016 and May 24, 2023.
What was the most recent Sanofi-Aventis U.S. LLC recall?
FDA recall D-0575-2023, published May 24, 2023: Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A Sanofi Company. NDC 0024-5926-05
Which agencies have handled Sanofi-Aventis U.S. LLC recalls?
Sanofi-Aventis U.S. LLC appears as the recalling firm in recalls from: FDA (16).

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