Sanofi Recalls Four Lots of H1N1 Vaccine

Sanofi Pasteur is recalling four lots of pediatric influenza A (H1N1) vaccine after routine stability testing discovered a decrease in potency after distribution.

The lots — 0.23-mL pre-filled syringes for children age 6 months to 35 months — were tested as part of Sanofi’s stability testing after distribution, the Centers for Disease Control and Prevention (CDC) said.

Sanofi had informed the CDC and the FDA that the potency in one distributed lot was found to have dropped below the company’s pre-specified potency limit. As a result, the company tested additional lots and found three had an antigen content that was adequate at the time of manufacture but was later found to be below potency limits.
Drug GMP Report