LIDOCAINE HYDROCHLORIDE

Generic: LIDOCAINE HYDROCHLORIDE

HospiraManufacturer

INFILTRATION, PERINEURALRoute

LIDOCAINE HYDROCHLORIDEActive Substance

1984-07-31Original Approval

LIDOCAINE HYDROCHLORIDE is FDA application ANDA088327, sponsored by HOSPIRA. 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 II2026-05-12

Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmin

Lack of Assurance of Sterility

Class I2013-12-23

Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials, 10 vials per box, Rx Only, Hospira

Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass conta

Class I2014-07-29

Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Single-Dose Vial, Rx only, For Infiltration and

Presence of Particulate Matter: The product was discolored and contained visible particulates (iron

Class I2013-09-16

1% Lidocaine HCl Injection, USP, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., Lake Forest, IL 60045.

Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride

Class II2021-11-30

Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured

Superpotent Drug: Minimally superpotent

Class II2015-08-25

1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx only, Hospira, Inc., Lake Fores

Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in t

Class III2018-04-30

Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-

Failed Stability Specifications

Class I2014-10-16

1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass vial (Twenty-five (25) units per b

Presence of particulate matter: A returned customer sample was evaluated and found to have human hai

Class II2020-07-14

Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake Cit

Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in

Class III2023-04-20

Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch

Labeling: Typographical error on the upper left-hand side of the box and individual patch label that

LIDOCAINE HYDROCHLORIDE

Recalls

Top Reported Reactions