USP Quality Review

No. 70, Issued November 1999

Gentamicin: Recalls

Both ESI Lederle and American Pharmaceutical Partners, Inc., had become aware of a higher than expected incidence of adverse experiences to particular gentamicin products. ESI Lederle issued an Urgent—Voluntary Market Withdrawal of 20 lots of Gentamicin Sulfate Injection, USP, on June 28, 1999. American Pharmaceutical Partners, Inc., issued a Voluntary Product Withdrawal of 17 lots of Gentamicin Sulfate Injection, USP, on August 17, 1999. The withdrawal letters distributed by each company cited that the involved products were manufactured using raw material from a specific supplier. Although the lots were reported to fully comply with product specifications for endotoxin levels, the companies nonetheless recalled the affected lots.

The gentamicin adverse event reports submitted to USP resulted from administration of lots that were the subject of withdrawals. It is extremely important that withdrawal or recall information be dispersed as quickly as it is received. Four of the reported incidents occurred after withdrawal of the involved product was announced.