FDA (Drugs) recall action 81413
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
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.
Avella of Deer Valley, Inc. is recalling 360 bags of Hydromorphone in NS due to a lack of assurance of sterility. The product was distributed nationwide.
Avella of Deer Valley is recalling 300 bags of Phenylephrine 30 mg in NS 250 mL due to a lack of assurance of sterility.
Avella of Deer Valley is recalling 20 syringes of Fentanyl (10 mcg/mL) in NS 1 mL due to a lack of assurance of sterility.
Avella of Deer Valley is recalling 300 bags of Phenylephrine 25 mg in NS 250 mL due to a lack of assurance of sterility.
Avella of Deer Valley is recalling 1,360 bags of Morphine in NS due to a lack of assurance of sterility. The product was distributed nationwide.