FDA (Drugs) recall action 87837
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.
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
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 163,957 vials of 0.5% Bupivacaine Hydrochloride Injection due to a label mix-up where some vials labeled as bupivacaine may contain lidocaine, and vials labeled as lidocaine may contain bupivacaine. The mix-up could lead to patients receiving the wrong local anesthetic.
Pfizer has recalled 139,050 vials of injectable anesthetic medications due to a label mix-up: some vials labeled as Lidocaine contain Bupivacaine, and some labeled as Bupivacaine contain Lidocaine. Patients and healthcare providers should verify medication identity before use.