Sanofi Aventis U S recalls

Sanofi Aventis U S appears in 22 official U.S. recall notices indexed by RecallRadar, most recently on 2023-05-24.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A San…
  FDA Drug · Class II · 2023-05-24 · Sanofi Aventis U S
  Reason: Lack of Assurance of Sterility: Malformed crimped collar seal
• Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75
  FDA Drug · Class II · 2020-08-26 · Sanofi Aventis U S
  Reason: Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
• Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 3740…
  FDA Drug · Class II · 2019-12-11 · Sanofi Aventis U S
  Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
• 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…
  FDA Drug · Class II · 2019-12-11 · Sanofi Aventis U S
  Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
• Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
  FDA Drug · Class II · 2019-12-11 · Sanofi Aventis U S
  Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
• Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
  FDA Drug · Class II · 2019-12-11 · Sanofi Aventis U S
  Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
• Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
  FDA Drug · Class II · 2019-12-11 · Sanofi Aventis U S
  Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
• Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
  FDA Drug · Class II · 2019-12-11 · Sanofi Aventis U S
  Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
• Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's:…
  FDA Drug · Class II · 2019-12-11 · Sanofi Aventis U S
  Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
• Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
  FDA Drug · Class II · 2019-12-11 · Sanofi Aventis U S
  Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
• Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
  FDA Drug · Class II · 2019-12-11 · Sanofi Aventis U S
  Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
• Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
  FDA Drug · Class II · 2019-12-11 · Sanofi Aventis U S
  Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
• Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
  FDA Drug · Class II · 2019-12-11 · Sanofi Aventis U S
  Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
• Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
  FDA Drug · Class II · 2019-12-11 · Sanofi Aventis U S
  Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
• Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physi…
  FDA Drug · Class II · 2018-07-18 · Sanofi Aventis U S
  Reason: Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
• 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
  FDA Drug · Class II · 2018-05-09 · Sanofi Aventis U S
  Reason: Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
• Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business of Sanofi-aventis,…
  FDA Drug · Class III · 2018-01-17 · Sanofi Aventis U S
  Reason: 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
• Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The Netherlands
  FDA Drug · Class III · 2017-11-08 · Sanofi Aventis U S
  Reason: Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
• Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tablets, 80 mg & 14.2 mg, 100-count bottles, Distribut…
  FDA Drug · Class III · 2017-07-05 · Sanofi Aventis U S
  Reason: Superpotent Drug: high out-of-specification result for magnesium.
• Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx Only, Manufactured by: Genzyme Corporation 500 Kendall Street,…
  FDA Drug · Class III · 2017-05-17 · Sanofi Aventis U S
  Reason: Labeling: Incorrect or Missing Package Insert
• 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…
  FDA Drug · Class I · 2016-06-01 · Sanofi Aventis U S
  Reason: Defective Delivery System; potential to have inaccurate dosage delivery
• Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0024-5831-02) and (b) 1 prefille…
  FDA Drug · Class I · 2016-06-01 · Sanofi Aventis U S
  Reason: Defective Delivery System; potential to have inaccurate dosage delivery