FDA (Drugs) recall action 75156
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.
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
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.
Hospira is recalling 4,768 vials of Marcaine 0.5% injection because a glass defect allowed water ingress, compromising sterility and reducing drug potency.
Hospira is recalling 15 vials of Marcaine 0.25% injection because a glass defect allowed water to enter, compromising sterility and reducing drug potency.