Sanofi-Aventis U.S. LLC

Bridgewater, NJ, United States

22

Total Recalls

2

Class I Recalls

15

Ongoing Recalls

Recalls by Sanofi-Aventis U.S. LLC

FDA Drug Class II Ongoing

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

April 11, 2023 Sanofi-Aventis U.S. LLC 51,325 vials units
FDA Drug Class II Ongoing

Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75

August 10, 2020 Sanofi-Aventis U.S. LLC 7451 vials units
FDA Drug Class II Ongoing

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 50269-222-25.

October 22, 2019 Sanofi-Aventis U.S. LLC
FDA Drug Class II Ongoing

Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 67751-151-01.

October 22, 2019 Sanofi-Aventis U.S. LLC
FDA Drug Class II Ongoing

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 67751-152-01 67751-152-02

October 22, 2019 Sanofi-Aventis U.S. LLC
FDA Drug Class II Ongoing

Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 66715-9736-2 66715-9736-3 66715-9736-8

October 22, 2019 Sanofi-Aventis U.S. LLC
FDA Drug Class II Ongoing

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's 41167-0300-0, 41167-0300-1, 41167-0300-3, 41167-0300-5, 4116

October 22, 2019 Sanofi-Aventis U.S. LLC
FDA Drug Class II Ongoing

Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 41167-0310-1 41167-0310-2 41167-0310-3 41167-0310-4 41167-0

October 22, 2019 Sanofi-Aventis U.S. LLC
FDA Drug Class II Ongoing

Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0121-01, 0597-0121-06, 0597-0121-08, 0597-0121-09, 0

October 22, 2019 Sanofi-Aventis U.S. LLC
FDA Drug Class II Ongoing

Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's: 41167-0320-1 41167-0320-2 41167-0320-3 41167-0320-

October 22, 2019 Sanofi-Aventis U.S. LLC
FDA Drug Class II Ongoing

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 68151-2584-0.

October 22, 2019 Sanofi-Aventis U.S. LLC
FDA Drug Class II Ongoing

Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 0597-0122-01 0597-0122-08 0597-0122-13 0597-0122-37 0597-0122-40 0597-0122-

October 22, 2019 Sanofi-Aventis U.S. LLC
FDA Drug Class II Ongoing

Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0120-06, 0597-0120-08, 0597-012

October 22, 2019 Sanofi-Aventis U.S. LLC
FDA Drug Class II Ongoing

Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 05269-220-25.

October 22, 2019 Sanofi-Aventis U.S. LLC
FDA Drug Class II Ongoing

Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample - Not For Sale, Sanofi-Aventis U.S. LLC, Bridgewa

July 5, 2018 Sanofi-Aventis U.S. LLC 3214 prefilled pens units
FDA Drug Class II Terminated

Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01

April 27, 2018 Sanofi-Aventis U.S. LLC 19580 vials units
FDA Drug Class III Terminated

Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business of Sanofi-aventis, U.S. LLC Bridgewater, NJ 08807, NDC 0955-1012-10

December 5, 2017 Sanofi-Aventis U.S. LLC 11,474 cartons of 10 syringes per carton units
FDA Drug Class III Terminated

Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The Netherlands; Mfd for: Winthrop U.S., a business of sanofi-aventis U.S. LLC, Brid

October 13, 2017 Sanofi-Aventis U.S. LLC 422 vials units
FDA Drug Class III Terminated

Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tablets, 80 mg & 14.2 mg, 100-count bottles, Distributed by: GlaxoSmithKline Consumer Healthcare, L.P., Moon Twp,

June 12, 2017 Sanofi-Aventis U.S. LLC 2980 bottles units
FDA Drug Class III Terminated

Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx Only, Manufactured by: Genzyme Corporation 500 Kendall Street, Cambridge, MA 02412 USA NDC: 0024-5862-01

September 1, 2016 Sanofi-Aventis U.S. LLC 2133 vials units
FDA Drug Class I Terminated

Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0024-5831-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5831-00), Rx Only, Manu

October 28, 2015 Sanofi-Aventis U.S. LLC 159,000 prefilled injectors units
FDA Drug Class I Terminated

Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5833-00), Rx Only, Manuf

October 28, 2015 Sanofi-Aventis U.S. LLC 383,900 prefilled syringes units