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Sanofi-Aventis U.S. LLC

Sanofi-Aventis U.S. LLC Recalls

All product recalls associated with Sanofi-Aventis U.S. LLC.

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Recall Summary

Total Recalls

15

Past Year

0

Class I (Serious)

0

Most Recent

Apr 2023

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–15 of 15 recalls

Admelog (Sanofi-Aventis) – Sterility Seal Issue (2023)

Lack of Assurance of Sterility: Malformed crimped collar seal

Class IIModerate

FDAApr 11, 2023Nationwide• Sanofi-Aventis U.S. LLC

Elitek Injection (Sanofi-Aventis) - Stability Failure (2020)

Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.

Class IIModerate

FDAAug 10, 2020Nationwide• Sanofi-Aventis U.S. LLC

Zantac Regular Strength (Sanofi) – NDMA impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Moderate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

Zantac Regular Strength (Sanofi) – NDMA impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

Zantac Regular Strength (Sanofi) – NDMA impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

Zantac (Sanofi) – NDMA Impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

Zantac Cool Mint Maximum Strength (Sanofi) – NDMA impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

Zantac Maximum Strength (Sanofi) – NDMA impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

Zantac Regular Strength (Sanofi) – NDMA Impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

Zantac Maximum Strength (Sanofi) – NDMA impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

Zantac Regular Strength (Sanofi) – NDMA impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

Zantac Cool Mint Tablets (Sanofi) – NDMA impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

Zantac Tablets (Sanofi) – NDMA impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

Zantac Regular Strength (Sanofi) – NDMA impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

Admelog Solostar (Sanofi-Aventis) – Temperature Abuse (2018)

Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.

Class IIModerate

FDAJul 5, 2018Nationwide• Sanofi-Aventis U.S. LLC