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Sanofi-Aventis U.S Recalls
22 recalls on record · June 1, 2016 to May 24, 2023 · Drugs
Recalls by year
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23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
May 24, 2023DrugsFDA
Sanofi-Aventis U.S. LLC recalls Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewa
Hazard: Lack of Assurance of Sterility: Malformed crimped collar seal
August 26, 2020DrugsFDA
Sanofi-Aventis U.S. LLC recalls Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC
Hazard: Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
December 11, 2019DrugsFDA
Sanofi-Aventis U.S. LLC recalls Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 0597
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
December 11, 2019DrugsFDA
Sanofi-Aventis U.S. LLC recalls Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 667
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
December 11, 2019DrugsFDA
Sanofi-Aventis U.S. LLC recalls Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
December 11, 2019DrugsFDA
Sanofi-Aventis U.S. LLC recalls Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
December 11, 2019DrugsFDA
Sanofi-Aventis U.S. LLC recalls Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-021
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
December 11, 2019DrugsFDA
Sanofi-Aventis U.S. LLC recalls Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
December 11, 2019DrugsFDA
Sanofi-Aventis U.S. LLC recalls Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-021
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
December 11, 2019DrugsFDA
Sanofi-Aventis U.S. LLC recalls Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
December 11, 2019DrugsFDA
Sanofi-Aventis U.S. LLC recalls Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
December 11, 2019DrugsFDA
Sanofi-Aventis U.S. LLC recalls Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
December 11, 2019DrugsFDA
Sanofi-Aventis U.S. LLC recalls Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
December 11, 2019DrugsFDA
Sanofi-Aventis U.S. LLC recalls Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, C
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
July 18, 2018DrugsFDA
Sanofi-Aventis U.S. LLC recalls Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per
Hazard: Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
May 9, 2018DrugsFDA
Sanofi-Aventis U.S. LLC recalls Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC
Hazard: Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
January 17, 2018DrugsFDA
Sanofi-Aventis U.S. LLC recalls Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business
Hazard: Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL
November 8, 2017DrugsFDA
Sanofi-Aventis U.S. LLC recalls Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The
Hazard: Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
July 5, 2017DrugsFDA
Sanofi-Aventis U.S. LLC recalls Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tablets, 80 mg & 14.2 mg, 100-count
Hazard: Superpotent Drug: high out-of-specification result for magnesium.
May 17, 2017DrugsFDA
Sanofi-Aventis U.S. LLC recalls Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx Only, Manufactured by: Genzyme Corporation
Hazard: Labeling: Incorrect or Missing Package Insert
June 1, 2016DrugsFDA
Sanofi-Aventis U.S. LLC recalls Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0024-5831-02)
Hazard: Defective Delivery System; potential to have inaccurate dosage delivery
June 1, 2016DrugsFDA
Sanofi-Aventis U.S. LLC recalls Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02)
Hazard: Defective Delivery System; potential to have inaccurate dosage delivery