Sanofi-Aventis U.S. recalls
FDA enforcement reports naming Sanofi-Aventis U.S. LLC as the recalling firm.
- Recall reports
- 22
- Class I (serious)
- 2
- Most recent report
- May 24, 2023
- May 24, 2023Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only,…Drug · Sanofi-Aventis U.S. LLCLack of Assurance of Sterility: Malformed crimped collar sealClass II
- Aug 26, 2020Elitek (rasburicase) for injection, 7Drug · Sanofi-Aventis U.S. LLCFailed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.Class II
- Dec 11, 2019Regular Strength Zantac 150 mg Distributed by: Chattem, IncDrug · Sanofi-Aventis U.S. LLCCGMP Deviations: Presence of NDMA impurity detected in product.Class II
- Dec 11, 2019Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, IncDrug · Sanofi-Aventis U.S. LLCCGMP Deviations: Presence of NDMA impurity detected in product.Class II
- Dec 11, 2019Maximum Strength Zantac 150 mg, Distributed by: Chattem, IncDrug · Sanofi-Aventis U.S. LLCCGMP Deviations: Presence of NDMA impurity detected in product.Class II
- Dec 11, 2019Regular Strength Zantac 150 mg, Distributed by: Chattem, IncDrug · Sanofi-Aventis U.S. LLCCGMP Deviations: Presence of NDMA impurity detected in product.Class II
- Dec 11, 2019Regular Strength Zantac 75 mg, Distributed by: Chattem, IncDrug · Sanofi-Aventis U.S. LLCCGMP Deviations: Presence of NDMA impurity detected in product.Class II
- Dec 11, 2019Regular Strength Zantac 75 mg, Distributed by: Chattem, IncDrug · Sanofi-Aventis U.S. LLCCGMP Deviations: Presence of NDMA impurity detected in product.Class II
- Dec 11, 2019Zantac 150 mg, Distributed by: Chattem, IncDrug · Sanofi-Aventis U.S. LLCCGMP Deviations: Presence of NDMA impurity detected in product.Class II
- Dec 11, 2019Zantac 75 mg, Distributed by: Chattem, IncDrug · Sanofi-Aventis U.S. LLCCGMP Deviations: Presence of NDMA impurity detected in product.Class II
- Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc
- Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc
- Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc
- Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc
- Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged…
- Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U
- Enoxaparin Sodium, Injection 120 mg/0
- Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharma…
- Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Ta…
- Mozobil (plerixafor injection) 24mg/1
- Auvi-Q (epinephrine injection, USP) Auto-Injector, 0
- Auvi-Q (epinephrine injection, USP) Auto-Injector, 0
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