Gentamicin Injection USP (10 mg/mL and 40 mg/mL) – Potential for Adverse Reactions with 12 Lots Contaminated with Histamine

Sandoz has identified histamine contamination in 3 Active Pharmaceutical Ingredient (API) batches used to manufacture 12 lots of Gentamicin Injection USP. The 3 API batches were tested for histamine levels. One batch had a level of 5 ppm (5 mcg/g), and the other 2 batches had a level less than the limit of quantification.

Product safety