FDA (Drugs) recall action 82918
The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
The agency’s own wording, quoted from the enforcement report.
Heritage Pharmaceuticals is recalling Prochlorperazine Edisylate Injection because microbial growth was detected in a sublot. The affected vials are distributed nationwide.
Heritage Pharmaceuticals is recalling Amikacin Sulfate Injection vials because microbial growth was detected in a sub-lot. The affected product is distributed nationwide in the USA.