FDA (Drugs) recall action 96636
The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
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.
Amerisource Health Services LLC is recalling Haloperidol Decanoate Injection due to lack of assurance of sterility and bacterial contamination detected in some media fill units. The affected product was distributed nationwide.
Amerisource Health Services LLC is recalling Haloperidol Decanoate Injection vials nationwide because some media fill units showed bacterial contamination, indicating a lack of sterility assurance. The affected product is a 100mg/mL injectable antipsychotic medication.
Amerisource Health Services LLC is recalling Haloperidol Decanoate Injection due to lack of assurance of sterility and bacterial contamination detected in some media fill units. The drug is used for intramuscular injection to treat psychiatric conditions.