BUPIVACAINE HYDROCHLORIDE WITH DEXTROSE

Generic: BUPIVACAINE HYDROCHLORIDE WITH DEXTROSE

B. Braun Medical Inc.Manufacturer

SUBARACHNOIDRoute

BUPIVACAINE HYDROCHLORIDEActive Substance

2019-04-02Original Approval

BUPIVACAINE HYDROCHLORIDE WITH DEXTROSE is FDA application ANDA209087, sponsored by B BRAUN MEDICAL. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class I2013-07-12

0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1159-

Presence of particulate matter: visible free floating and partially embedded particulate matter in t

Class II2022-04-13

Bupivacaine Hydrochloride, USP 0.5% (5mg/mL), 25 vials x 50 mL per box, Rx only, MFG: Pfizer, NDC 0409-1163-01

cGMP deviations: Temperature abuse

Class I2013-07-12

0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1165-

Presence of particulate matter: visible free floating and partially embedded particulate matter in t

Class II2014-02-10

Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest,

Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the gla

Class II2013-10-11

0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake For

Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.

Class I2015-04-23

Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC.,

Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.

Class I2021-05-03

0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 0409-1162-19

Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP

Class I2016-08-04

Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, H

Presence of particulate matter: Confirmed customer report for the presence of particulate matter wit

Class II2013-09-05

0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Fore

Lack of Assurance of Sterility; potential for vial breakage

Class II2026-04-02

Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured

BUPIVACAINE HYDROCHLORIDE WITH DEXTROSE

Recalls

Top Reported Reactions