FDA (Drugs) recall action 79114
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.
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
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.
Pfizer is recalling 29,680 vials of Hydromorphone Hydrochloride Injection due to confirmed customer complaints of empty or cracked glass containers.
Pfizer is recalling 53,600 vials of Hydromorphone Hydrochloride Injection due to confirmed customer complaints of empty or cracked glass vials.