sanofi-aventis US, Inc.

FDA Regulatory Profile

sanofi-aventis US, Inc. appears in FDA public data with 3 recalls, 0 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0609-2013, Class II) was initiated on September 21, 2012.

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Known Names

sanofi-aventis us, sanofi-aventis u.s, sanofi-aventis, u.s

Recent Recalls

NumberClassProductDate
Z-0609-2013Class IIDiamigo i-Phone App The Diamigo app was intended for use as an educational tool in the managemenSeptember 21, 2012
D-1408-2012Class IIEloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLFebruary 6, 2012
D-1407-2012Class IIEloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC February 6, 2012