FDA (Drugs) recall action 68841
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: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.
Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Unique Pharmaceutical, Ltd is recalling one lot of N-Acetyl Cysteine 20% vials because testing revealed the presence of Herbaspirillum huttiense bacteria.
Unique Pharmaceutical, Ltd is recalling all sterile products due to poor aseptic production practices identified by an FDA inspection.