Overview of recall records associated with Sanofi-Aventis U.S. LLC, including dates, categories and classifications where available.
Classification mix: Class II: 4, Class III: 3, Class I: 2.
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
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
Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
Superpotent Drug: high out-of-specification result for magnesium.
Defective Delivery System; potential to have inaccurate dosage delivery
Defective Delivery System; potential to have inaccurate dosage delivery
This page summarizes recall records in which the official source identifies Sanofi-Aventis U.S. LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
