FDA (Drugs) recall action 98724
The FDA (Drugs) publishes a recall like this one as 4 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 4 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.
0.9% Sodium Chloride Injection, USP in 10 mL single dose ampules supplied for Spectra Medical Devices is being recalled for lack of assurance of sterility. 7,120,750 ampules are affected.
Lidocaine HCl Injection, USP 2% in 5 mL single-dose vials manufactured by Huons is being recalled for lack of assurance of sterility. All lots within expiry are affected.
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP ampules are being recalled for lack of assurance of sterility. The action covers 3,260,170 ampules.
Lidocaine HCl Injection, USP 1% in 5 mL single dose vials manufactured by Huons is being recalled for lack of assurance of sterility. All lots within expiry are affected.