Sanofi-Aventis U.S. LLC

FDA Regulatory Profile

Summary

Total Recalls
22 (2 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0575-2023Class IIAdmelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-AventiApril 11, 2023
D-1507-2020Class IIElitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC BridgewaAugust 10, 2020
D-0540-2020Class IIRegular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, ChattaOctober 22, 2019
D-0541-2020Class IIRegular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, ChattOctober 22, 2019
D-0544-2020Class IIZantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-October 22, 2019
D-0535-2020Class IIRegular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, ChattaOctober 22, 2019
D-0537-2020Class IIRegular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, ChattaOctober 22, 2019
D-0539-2020Class IIMaximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, ChattOctober 22, 2019
D-0545-2020Class IIZantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0October 22, 2019
D-0538-2020Class IICool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2October 22, 2019
D-0543-2020Class IIRegular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, ChattaOctober 22, 2019
D-0542-2020Class IIRegular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, ChattaOctober 22, 2019
D-0536-2020Class IIMaximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, ChattaOctober 22, 2019
D-0534-2020Class IICool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi CompOctober 22, 2019
D-0925-2018Class IIAdmelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilJuly 5, 2018
D-0804-2018Class IIDocetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-AvApril 27, 2018
D-0153-2018Class IIIEnoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, WinthDecember 5, 2017
D-0056-2018Class IIIClofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, SwensOctober 13, 2017
D-0926-2017Class IIIGaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tablets, 80 mg June 12, 2017
D-0704-2017Class IIIMozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx Only, Manufactured by: September 1, 2016