FDA (Drugs) recall action 66260
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.
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
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 Inc. is recalling 119,600 vials of Bupivacaine Hydrochloride Injection due to the presence of visible particulate matter.
Hospira Inc. is recalling 118,100 vials of 0.25% Bupivacaine Hydrochloride Injection due to the presence of visible particulate matter.