FDA (Drugs) recall action 96569
The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.
Lack of Assurance of Sterility: Media fill with bacterial contamination
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.
Somerset Therapeutics is recalling Haloperidol Decanoate Injection due to lack of assurance of sterility resulting from bacterial contamination detected during media fill testing. The recall affects 23,960 vials distributed nationwide.
Somerset Therapeutics is recalling Haloperidol Decanoate Injection 50mg/mL vials nationwide due to lack of assurance of sterility from bacterial contamination detected in media fill testing.
Somerset Therapeutics is recalling Methocarbamol Injection USP (1,000 mg/10 mL vials) nationwide due to lack of assurance of sterility following bacterial contamination in media fill testing.
Somerset Therapeutics is recalling Haloperidol Decanoate Injection (100 mg/mL, 1 mL vials) due to lack of assurance of sterility caused by bacterial contamination detected in media fill testing.
Somerset Therapeutics is recalling 997 vials of Haloperidol Decanoate Injection 50mg/mL nationwide due to lack of assurance of sterility following bacterial contamination detected in a media fill validation test.