RecallDepth
Class II Terminated

Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-461-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-461-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

This recall has been terminated (originally issued January 25, 2023).

Company
Fresenius Kabi Usa, Llc
Recall Initiated
November 22, 2022
Posted
January 25, 2023
Recall Number
D-0127-2023
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
40,375 vials
Firm Location
Lake Zurich, IL, United States
Official Source
View on FDA website ↗

Reason for Recall

Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Distribution

Nationwide in the USA

Lot / Code Info

Batch #: 6128061, exp 03/2024; 6128663, 6128664, exp 05/2024

More recalls by Fresenius Kabi Usa, Llc

View all recalls by this company →

Other recent Class II Drug recalls