RecallRadar

FDA Drug recall D-0129-2023

Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg…

On 2023-01-25 the FDA classified a Class II recall of Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg… by Fresenius Kabi Usa, citing subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0129-2023
ClassificationClass II
Statusterminated
Initiated2022-11-22
Published2023-01-25
Last updated2026-09-13 11:52 UTC
CompanyFresenius Kabi Usa
DistributionUS

Product

Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg per mL), 10 mL Single Dose Vial (NDC 63323-468-01), packaged in 25 Single Dose Vials per tray (NDC 63323-468-17), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Reason

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

Identifiers

ndc63323-472-03
ndc63323-472-17
ndc63323-472-01
ndc63323-472-37
ndc63323-463-01
ndc63323-463-57
ndc63323-461-01
ndc63323-461-57
ndc63323-468-02
ndc63323-468-37
ndc63323-468-01
ndc63323-468-17
code_infoBatch #: 6128800, exp 12/2023

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0129-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.